BETAMOX PALATABLE DROPS

Australia - English - APVMA (Australian Pesticides and Veterinary Medicines Authority)

Buy It Now

Active ingredient:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE
Available from:
NORBROOK LABORATORIES AUSTRALIA PTY LIMITED
INN (International Name):
amoxycillin as trihydrate(100mg/g)
Pharmaceutical form:
ORAL SOLUTION/SUSPENSION
Composition:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 750.0 mg
Units in package:
7.5g
Class:
VM - Veterinary Medicine
Therapeutic group:
CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
ANTIBIOTICS - ORAL, PARENTERAL | AIRSACCULITIS | AMOXYCILLIN SENSITIVE BACTERIA | ANAEROBIC BACTERIAL INFECTION | AVIAN MYCOPLASMAS | CLAVULANIC ACID SENSITIVE | COCCIDIOSIS | CORYZA | CRD | DERMATOSES | DIARRHOEA | ENDOMETRITIS | ENTERITIS | ENZOOTIC PNEUMONIA | ESCHERICHIA COLI | EUROPEAN BROOD DISEASE | GENTAMICIN SENSITIVE | HYPERMOTILITY | INFECTED WOUNDS | INFECTIONS | LACTATING | MASTITIS | PROTOZOAL INFECTIONS | PYOMETRA | SALMONELLOSIS | SINUSITIS | SYSTEMIC BACTERIAL INFECTION
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [ANTIBIOTICS - ORAL, PARENTERAL]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL]; Poison schedule: 4; Withholding period: ; Host/pest details: CAT: [ANTIBIOTICS - ORAL, PARENTERAL]; DOG: [ANTIBIOTICS - ORAL, PARENTERAL]; For treatment of infections caused by organisms sensitive to amoxycillin in dogs and cats.Do not administer to penicillin sensitive animals. Should not be used orally or parenterally in rabbits or guinea pigs. Caution is advised when used in other very small herbivores.
Authorization status:
Stopped
Authorization number:
51974
Authorization date:
2019-06-30

·--'

DRAFT TEXT LABEL -

BETAMQX Injection

IMMEDIATE CONTAINER:

MAIN PANEL

Text

appearing

abave

and

beI(M1

the

header

and

footer

lines

is

not

included

inthe I

PRESCRIPTION ANIMAL REM DY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

BETAMOX Palatable Drops

Amoxycillin trihydrate

(equivalent to amoxycillin 750 mg)

[Norbrook Logo]

N.R.A.

APPROVED

LABEL

(TEXT)

.

"5'1'11't

!ot{'C!

Label

Date:

..'~.

.I.q,f.

..

Ji!!P(

Signature:

2610412001

Page1of6

DRAFT TEXT LABEL -

BETAMOX Injection

IMMEDIATE CONTAINER:

ANCILLARY PANEL

Text

appearing

above

and

below

the headerand

footer

lines

is not

included

in the

label.

Contents:

Amoxycillin Trihydrate equivalent to 750 mg amoxycillin.

The powder should be reconstituted with 12 mL water to give a 15 mL suspension

containing amoxycillin at a concentration of

50 mg/mL.

Do not administer to penicillin sensitive animals.

As with other penicillins,

amoxycillin

should not

be used orally or parenterally in rabbits or guinea pigs.

Caution is advised when

used in any other very small

herbivores.

Dosage and Administration:

Shake well

before use.

Discard unused suspension after seven days.

Dogs and Cats:

1 mL per 5 kg bodyweight twice daily for up to seven days.

Dispose of empty container by wrapping with paper and putting in garbage.

Store below 25°C (Air Conditioning).

Protect

from light.

NRA51974/

osc!

[Norbrook Logo]

Manufactured by:

Norbrook Laboratories Ltd,

Distributed by:

Norbrook Laboratories Australia Pty Limited

AC.N.

080 972 596

5/12 Ladd Road

Gisbome,

'\lie

3437

(8):

EXP:

26/04/01

Page2of6

DRAFT TEXT LABEL -

BETAMOX Injection

CARTON:

FRONT

&

BACK

PANELS

Text

appearing

eboe

and

belON

the

header

and

footer

lines

is

not

included

in the

label.

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

BETAMOX Palatable Drops

Amoxycillin trihydrate

(equivalent to amoxycillin 750 mg)

[Norbrook Logo

26/04/01

Page3of6

DRAFT TEXT

lABEL

BETAMQX Injection

CARTON:

SIDE PANEL 1

Text

appearing

above

and

belaN

the

header

and

footer

lines

is

not

included

in the

label.

BETAMOX

Palatable Drops

CONTRA-INDICATIONS

Amoxycillin should not be given to penicillin sensitive animals.

DOSAGE AND ADMINISTRATION

NOT FOR USE in food producing animals.

The powder should be reconstituted with 12 mL of water to give a 15 mL suspension

containing amoxycillin at a concentration of 50

mg/mL.

Shake well

before use.

Administer orally,

using the graduated pipette provided,

at a rate of

mg/kg

bodyweight,

twice daily for up to 7 days.

The dosage rate of

mg/kg

is achieved by administering 1

mL of reconstituted product

per 5 kg bodyweight.

As one drop from the pipette provided

contains 2.5 mg amoxycillin,

administration of four drops per kg twice daily will

achieve the

recommended dosage.

Discard unused suspension after seven days.

26104/01

Page4of6

DRAFT TEXT"

lABEL

BETAMOX Injection

CARTON:

SIDE PANEL

Text

appearing

eooe

and

belON

the

header

and

footer

lines

is

not

included

in the

label.

BETAMOX

Palatable Drops

For treatment of

infections caused by organisms sensitive to amoxycillin in dogs and cats.

7.5 g NET

Dispose of empty container by wrapping with paper and putting in garbage.

Store below 25°C (Air Conditioning)

Protect

from light.

NRA51974/

Os-of

[Norbrook Logo]

Manufactured by:

Norbrook Laboratories Ltd,

Distributed by:

Norbrook Laboratories Australia Pty Limited

A.C.N.

080972

5/12 Ladd Road

Gisbome,

3437

26104/01

Page5of6

DRAFT TEXT

lABEL

BETAMOX

Injection

IMMEDIATECONTAINER:

ANCILLARYPANEL

Text

appearing

abo\.e

and

belON

the

header

and

footer

lines

is not

included

in the

label.

BETAMOX

Palatable Drops

7.5 9 NET

26104/01

Page6

Product Name: Betamox Palatable Drops

Page: 1 of 4

This revision issued: September, 2009

MATERIAL SAFETY DATA SHEET

Issued by: Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Section 1 - Identification of Chemical Product and Company

Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

Unit 7/1 Trade Park Drive

Tullamarine, Vic 3043 AUSTRALIA

Substance:

Antibiotic preparation in a suitable medium.

Trade Name:

Betamox Palatable Drops

APVMA Code:

51974

Product Use:

For treatment of infections due to Amoxycyllin sensitive organisms in dogs and cats.

Creation Date:

September, 2009

This version issued:

September, 2009

and is valid for 5 years from this date.

Section 2 - Hazards Identification

Statement of Hazardous Nature

This product is classified as:

Not classified as hazardous according to the criteria of SWA.

Not a Dangerous Good according to the Australian Dangerous Goods (ADG) Code.

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

S36, S24/25. Wear suitable protective clothing. Avoid contact with skin and eyes.

SUSDP Classification:

ADG Classification:

None allocated. Not a Dangerous Good under the ADG Code.

UN Number:

None allocated

Emergency Overview

Physical Description & Colour

: Off-white suspension.

Odour:

No odour.

Major Health Hazards:

This is an antibiotic preparation. Any person with a history of allergies to this class of

substances should avoid all contact with this product as it may cause sensitisation. This is a physiologically active

product and so contact should be minimised, especially if the user is taking a form of medication, as interactions can

sometimes give unexpected and undesired results.

Potential Health Effects

Inhalation:

Short Term Exposure:

Available data indicates that this product is not harmful. However product may be mildly

irritating, although unlikely to cause anything more than mild transient discomfort.

Long Term Exposure:

No data for health effects associated with long term inhalation.

Skin Contact:

Short Term Exposure:

Available data indicates that this product is not harmful. It should present no hazards in

normal use. However product may be mildly irritating, but is unlikely to cause anything more than mild discomfort

which should disappear once contact ceases.

Long Term Exposure:

No data for health effects associated with long term skin exposure.

Eye Contact:

Short Term Exposure

: This product may be irritating to eyes, but is unlikely to cause anything more than mild

transient discomfort.

Long Term Exposure

: No data for health effects associated with long term eye exposure.

Ingestion:

Short Term Exposure

: Significant oral exposure is considered to be unlikely. However, this product may be

irritating to mucous membranes but is unlikely to cause anything more than transient discomfort.

Long Term Exposure

: No data for health effects associated with long term ingestion.

Carcinogen Status:

SWA:

No significant ingredient is classified as carcinogenic by SWA.

NTP:

No significant ingredient is classified as carcinogenic by NTP.

IARC:

No significant ingredient is classified as carcinogenic by IARC.

Product Name: Betamox Palatable Drops

Page: 2 of 4

This revision issued: September, 2009

MATERIAL SAFETY DATA SHEET

Issued by: Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Section 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Amoxycyllin trihydrate

61336-70-7

150mg/mL

not set

not set

Other non hazardous ingredients

secret

to 100

not set

not set

This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non

hazardous ingredients are also possible.

The SWA TWA exposure value is the average airborne concentration of a particular substance when calculated over a normal 8 hour working day

for a 5 day working week. The STEL (Short Term Exposure Limit) is an exposure value that may be equalled (but should not be exceeded) for no

longer than 15 minutes and should not be repeated more than 4 times per day. There should be at least 60 minutes between successive exposures

at the STEL. The term "peak "is used when the TWA limit, because of the rapid action of the substance, should never be exceeded, even briefly.

Section 4 - First Aid Measures

General Information:

You should call The Poisons Information Centre if you feel that you may have been poisoned, burned or irritated by

this product. The number is 13 1126 from anywhere in Australia (0800 764 766 in New Zealand) and is available at all

times. Have this MSDS with you when you call.

Inhalation:

First aid is not generally required. If in doubt, contact a Poisons Information Centre or a doctor.

Skin Contact:

Irritation is unlikely. However, if irritation does occur, flush with lukewarm, gently flowing water for 5

minutes or until chemical is removed.

Eye Contact:

No effects expected. If irritation does occur, flush contaminated eye(s) with lukewarm, gently flowing

water for 5 minutes or until the product is removed. Obtain medical advice if irritation becomes painful or lasts more

than a few minutes. Take special care if exposed person is wearing contact lenses.

Ingestion:

If product is swallowed or gets in mouth, do NOT induce vomiting; wash mouth with water and give some

water to drink. If symptoms develop, or if in doubt contact a Poisons Information Centre or a doctor.

Section 5 - Fire Fighting Measures

Fire and Explosion Hazards

: There is no risk of an explosion from this product under normal circumstances if it is

involved in a fire.

Only small quantities of decomposition products are expected from this products at temperatures normally achieved in

a fire. This will only occur after heating to dryness.

Fire decomposition products from this product are not expected to be hazardous or harmful.

Extinguishing Media

: Not Combustible. Use extinguishing media suited to burning materials.

Fire Fighting

: If a significant quantity of this product is involved in a fire, call the fire brigade.

Flash point

:

Does not burn.

Upper Flammability Limit:

Does not burn.

Lower Flammability Limit:

Does not burn.

Autoignition temperature:

Not applicable - does not burn.

Flammability Class:

Does not burn.

Section 6 - Accidental Release Measures

Accidental release

: This product is sold in small packages, and the accidental release from one of these is not

usually a cause for concern. For minor spills, clean up, rinsing to sewer and put empty container in garbage. Although

no special protective clothing is normally necessary because of occasional minor contact with this product, it is good

practice to wear impermeable gloves when handling chemical products. In the event of a major spill, prevent spillage

from entering drains or water courses and call emergency services.

Section 7 - Handling and Storage

Handling

: Keep exposure to this product to a minimum, and minimise the quantities kept in work areas. Check

Section 8 of this MSDS for details of personal protective measures, and make sure that those measures are followed.

The measures detailed below under "Storage" should be followed during handling in order to minimise risks to

persons using the product in the workplace. Also, avoid contact or contamination of product with incompatible

materials listed in Section 10.

Storage

: This product is a Scheduled Poison. Observe all relevant regulations regarding sale, transport and storage

of this schedule of poison. Protect this product from light. Store in the closed original container in a dry, cool, well-

ventilated area out of direct sunlight. Make sure that the product does not come into contact with substances listed

under "Incompatibilities" in Section 10. Some liquid preparations settle or separate on standing and may require

stirring before use. Check packaging - there may be further storage instructions on the label.

Product Name: Betamox Palatable Drops

Page: 3 of 4

This revision issued: September, 2009

MATERIAL SAFETY DATA SHEET

Issued by: Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Section 8 - Exposure Controls and Personal Protection

The following Australian Standards will provide general advice regarding safety clothing and equipment:

Respiratory equipment: AS/NZS 1715, Protective Gloves: AS 2161, Industrial Clothing: AS2919, Industrial Eye

Protection: AS1336 and AS/NZS 1337, Occupational Protective Footwear: AS/NZS2210.

SWA Exposure Limits

TWA (mg/m

3

)

STEL (mg/m

3

)

Exposure limits have not been established by SWA for any of the significant ingredients in this product.

The ADI for Amoxycillin is set at 0.2mg/kg/day. The corresponding NOEL is set at 200mg/kg/day. ADI means

Acceptable Daily Intake; NOEL means No-observable-effect-level. Taken from Australian ADI List, Dec 2008.

No special equipment is usually needed when occasionally handling small quantities. The following instructions are

for bulk handling or where regular exposure in an occupational setting occurs without proper containment systems.

Ventilation:

No special ventilation requirements are normally necessary for this product. However make sure that

the work environment remains clean and that vapours and mists are minimised.

Eye Protection:

Eye protection such as protective glasses or goggles is recommended when this product is being

used.

Skin Protection:

The information at hand indicates that this product is not harmful and that normally no special skin

protection is necessary. However, we suggest that you routinely avoid contact with all chemical products and that you

wear suitable gloves (preferably elbow-length) when skin contact is likely.

Protective Material Types:

We suggest that protective clothing be made from the following materials: rubber,

PVC.

Respirator:

Usually, no respirator is necessary when using this product. However, if you have any doubts consult

the Australian Standard mentioned above.

Safety deluge showers should, if practical, be provided near to where this product is being used.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

Off-white suspension.

Odour:

No odour.

Boiling Point:

Approximately 100°C at 100kPa.

Freezing/Melting Point:

Below 0°C.

Volatiles:

Water component.

Vapour Pressure:

2.37 kPa at 20°C (water vapour pressure).

Vapour Density:

No data.

Specific Gravity:

1.00 approx

Water Solubility:

Completely soluble in water.

pH:

No data.

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water Distribution

No data

Autoignition temp:

Not applicable - does not burn.

Section 10 - Stability and Reactivity

Reactivity:

This product is unlikely to react or decompose under normal storage conditions. However, if you have

any doubts, contact the supplier for advice on shelf life properties.

Conditions to Avoid:

Protect this product from light. Store in the closed original container in a dry, cool, well-

ventilated area out of direct sunlight.

Incompatibilities:

No particular Incompatibilities.

Fire Decomposition:

Only small quantities of decomposition products are expected from this products at

temperatures normally achieved in a fire. This will only occur after heating to dryness. Carbon dioxide, and if

combustion is incomplete, carbon monoxide. Nitrogen and its compounds, and under some circumstances, oxides of

nitrogen. Occasionally hydrogen cyanide gas in reducing atmospheres. Oxides of sulfur (sulfur dioxide is a respiratory

hazard) and other sulfur compounds. Most will have a foul odour. Water. Carbon monoxide poisoning produces

headache, weakness, nausea, dizziness, confusion, dimness of vision, disturbance of judgment, and

unconsciousness followed by coma and death.

Polymerisation:

This product will not undergo polymerisation reactions.

Section 11 - Toxicological Information

Local Effects:

Product Name: Betamox Palatable Drops

Page: 4 of 4

This revision issued: September, 2009

MATERIAL SAFETY DATA SHEET

Issued by: Norbrook Laboratories Australia Pty Ltd

Freecall: 1800 665 866

Poisons Information Centre: 13 1126 from anywhere in Australia, (0800 764 766 in New Zealand)

Target Organs:

There is no data to hand indicating any particular target organs.

Classification of Hazardous Ingredients

Ingredient

Risk Phrases

No ingredient mentioned in the HSIS Database is present in this product at hazardous concentrations.

Section 12 - Ecological Information

Insufficient data to be sure of status. Expected to not be an environmental hazard.

Section 13 - Disposal Considerations

Disposal:

Dispose of small quantities and empty containers by wrapping with paper and putting in garbage. For

larger quantities, if recycling or reclaiming is not possible, use a commercial waste disposal service.

Section 14 - Transport Information

ADG Code:

This product is not classified as a Dangerous Good. No special transport conditions are necessary

unless required by other regulations.

Section 15 - Regulatory Information

AICS:

All of the significant ingredients in this formulation are compliant with NICNAS regulations.

The following ingredient: Amoxycyllin, is mentioned in the SUSDP.

Section 16 - Other Information

This MSDS contains only safety-related information. For other data see product literature.

Acronyms:

ADG Code

Australian Code for the Transport of Dangerous Goods by Road and Rail (7

edition)

AICS

Australian Inventory of Chemical Substances

SWA

Safe Work Australia, formerly ASCC and NOHSC

CAS number

Chemical Abstracts Service Registry Number

Hazchem Code

Emergency action code of numbers and letters that provide information to emergency

services especially firefighters

IARC

International Agency for Research on Cancer

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSDP

Standard for the Uniform Scheduling of Drugs & Poisons

UN Number

United Nations Number

THIS MSDS SUMMARISES OUR BEST KNOWLEDGE OF THE HEALTH AND SAFETY HAZARD INFORMATION OF THE PRODUCT AND

HOW TO SAFELY HANDLE AND USE THE PRODUCT IN THE WORKPLACE. EACH USER MUST REVIEW THIS MSDS IN THE CONTEXT OF

HOW THE PRODUCT WILL BE HANDLED AND USED IN THE WORKPLACE.

IF CLARIFICATION OR FURTHER INFORMATION IS NEEDED TO ENSURE THAT AN APPROPRIATE RISK ASSESSMENT CAN BE MADE,

THE USER SHOULD CONTACT THIS COMPANY SO WE CAN ATTEMPT TO OBTAIN ADDITIONAL INFORMATION FROM OUR SUPPLIERS

OUR RESPONSIBILITY FOR PRODUCTS SOLD IS SUBJECT TO OUR STANDARD TERMS AND CONDITIONS, A COPY OF WHICH IS SENT

TO OUR CUSTOMERS AND IS ALSO AVAILABLE ON REQUEST.

Please read all labels carefully before using product.

This MSDS is prepared in accord with the SWA document “National Code of Practice for the Preparation of

Material Safety Data Sheets” 2nd Edition [NOHSC:2011(2003)]

Copyright © Kilford & Kilford Pty Ltd, September, 2009.

http://www.kilford.com.au/

Phone (02)9251 4532

Similar products

Search alerts related to this product

View documents history

Share this information