AMOXYCLAV 200 BROADSPECTRUM ANTIBIOTIC TABLETS

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

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Active ingredient:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE; CLAVULANIC ACID (AS POTASSIUM SALT)
Available from:
Dechra Veterinary Products (Australia) Pty. Ltd.
INN (International Name):
amoxycillin as trihydrate(160mg/Tb) + others
Pharmaceutical form:
ORAL TABLET
Composition:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 160.0 mg/Tb; CLAVULANIC ACID (AS POTASSIUM SALT) ANTIBIOTIC Active 40.0 mg/Tb
Units in package:
100 Tabs; 150 tablets; 180 tablets; 20 Tablets; 200 Tabs; 210 tablets; 240 tablets; 250 Tabs; 270 tablets; 300 tablets; 330 tabl
Class:
VM - Veterinary Medicine
Manufactured by:
APEX LABORATORIES
Therapeutic group:
CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
BACTERIAL INFECTION | AMOXYCILLIN SENSITIVE BACTERIA | ASSOCIATED WITH VIRAL DISEASE | GRAM NEGATIVE ORGANISMS | GRAM POSITIVE ORGANISMS | POST PARTURIENT BACTERIAL INFE | PRIMARY BACTERIAL INFECTION | SULFADIAZINE SENSITIVE BACTERI | TRIMETHOPRIM SENSITIVE BACTERI | TYLOSIN SENSITIVE BACTERIA
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [BACTERIAL INFECTION]; DOG: [BACTERIAL INFECTION]; For the treatment of bacterial infections caused by organisms sensitive to amoxycillin and clavulanic acid in dogs and cats.Contraindicated in animals with a history of allergic reactions to penicillins. Contraindicated in small herbivores (e.g. rabbits, guinea pigs)
Authorization status:
Registered
Authorization number:
53274
Authorization date:
2020-07-01

For Official Use Only

e-Label Application (DRAFT)

Company Name:

APEX LABORATORIES PTY LTD

Product Name:

AMOXYCLAV 200 BROADSPECTRUM ANTIBIOTIC TABLETS

eLabel Application No:

DC12-66367748E18

APVMA Approval No:

53274/101248

Product No:

53274

Version No:

Application Started:

2014-Dec-17 15:20:28

Version Created:

2015-Apr-09 16:22:38

Started By:

Rebecca Skinner

Printed:

2015-Apr-09 16:24:23

Label Name:

AMOXYCLAV 200 BROADSPECTRUM ANTIBIOTIC TABLETS

Signal Headings:

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Constituent

Statements:

Each tablet contains:

160 mg AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE

40 mg CLAVULANIC ACID (AS POTASSIUM SALT)

Claims:

Treatment of bacterial infections caused by organisms sensitive to amoxycillin and

clavulanic acid in dogs and cats.

Net Contents:

100 Tabs

200 Tabs

250 Tabs

50 Tablets

500 Tabs

20 tablets

Directions for Use:

For oral administration only.

Contraindications:

This product is contraindicated for use in animals with a history of allergic reactions to

penicillins.

This product is contraindicated for use in small herbivores (eg rabbits, guinea pigs).

Dosage and

Administration:

DOGS AND CATS

12.5mg/kg bodyweight twice daily

Dose rates of up to 25mg/kg bodyweight have shown to be effective in refractory cases.

Duration of therapy is typically 5-7 days or for 48 hours after clinical signs have subsided.

Longer duration of therapy (up to 28 days) is recommended for chronic cystitis and

dermatitis conditions.

RLP

APPROVED

For Official Use Only

First Aid

Instructions:

If poisoning occurs contact a doctor or Poisons Information Centre. Phone 131 126.

First Aid Warnings:

Disposal:

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

Storage:

Store below 25°C (air conditioning).

Protect from light.

Material Safety Data Sheet

Amoxyclav 50, 200, 250 and 500 Broadspectrum Antibiotic Tablets

Classified as hazardous according to the criteria of NOHSC

Product Name

Amoxyclav 50, 200, 250 and 500 Broadspectrum Antibiotic Tablets

Recommended Use

Treatment of bacterial infections sensitive to amoxycillin and clavulanic

acid.

Supplier Details

Apex Laboratories Pty. Ltd.

ACN Number

000 397 240

Street

61 Chivers Road

Suburb

Somersby

State

Country

Australia

Post Code

2250

Phone

+61 2 4372 1661 (Business hours – 8.30am – 5.00pm)

+61 2 4372 1668 (fax)

Website

http://www.apexlabs.com.au

Emergency contact

As above or Poisons Information Centre 131126 (Australia)

Classification

Classified as hazardous according to the criteria of NOHSC

Risk Phrases

R42/43 May cause sensitisation by inhalation and skin contact

Safety Phrases

None allocated

ADG Class

None allocated

Hazchem Code

None allocated

Poisons Schedule

Ingredients

CAS No

Proportion

TWA mg/m3

STEL mg/m3

Amoxycillin

61336-70-7

30-60%

not set

not set

Clavulanic Acid

61177-45-5

<10%

not set

not set

Other non hazardous ingredients

to 100%

The 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 over an entire working lifetime. The TWA exposure standard set by Worksafe Australia for dusts not otherwise specified is 10mg/m3. The

STEL (Short Term Exposure Limit) is an exposure value that should not be exceeded for more than 15 minutes and should not be repeated for more than 4

times per day. There should be at least 60 minutes between successive exposures at the STEL.

Ingestion

Generally not required. If concerned rinse mouth with water, give water to

drink and seek medical advice.

Immediately flush eye(s) with lukewarm water for 20 minutes holding

eyelids open.Seek medical advice.

Skin

Generally not required. If concerned wash well with soap and water and

seek medical advice.

Inhalation

Generally not required. If concerned move to fresh air and seek medical

advice.

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MSDS|Amoxyclav 50, 200, 250 and 500 Broadspectrum Antibiotic Tablets

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/4/Amoxyclav+50%2C+200%2C+250+and+500+Broadspectrum+Antibiotic+Tablets/pdf

Copyright © 2005 Apex Laboratories Pty. Ltd. All rights reserved.

SECTION I Identification of the Material and Supplier

SECTION II Hazard Identification

SECTION III Composition

SECTION IV First Aid Measures

SECTION V Fire Fighting Measures

Extinguishing Media

Foam, dry chemical powder, carbon dioxide, water spray (large fires). As

appropriate for surrounding materials.

Combustion Hazards

Toxic fumes may be emitted under fire conditions.

Precautions for Firefighters

Wear breathing apparatus.

Hazchem Code

None allocated

Emergency Procedures

Spillage of formulated product from marketed packaging is unlikely to ever

be serious, however, in the event of a major spill, protect drains and water

courses from contamination.

Materials and Methods

Wear protective clothing (overalls, goggles, gloves and boots) and prevent

further spillage. Shovel spillage into labelled containers and dispose after

consulting appropriate authorities.

Precautions

Always use good occupational work practices and observe

recommendations on the label. Keep exposure to this product to a

minimum. Prohibit eating, drinking and smoking in storage and handling

areas. Wash hands after handling and remove contaminated clothing and

any protective equipment before entering eating areas.

Conditions

Store product in original containers as per label instruction (below 25oC,

air conditioning).

National Exposure Standards

No exposure standard has been allocated for this mixture or any

significant ingredient within this mixture.

Biological Limit Values

No biological limit has been allocated for this mixture.

Engineering Controls

No specific engineering controls are required for this mixture.

Personal Protective Equipment

Eye protection is not normally necessary. If concerned wear protective

goggles or glasses.

Skin

Skin protection is not normally necessary, however it is good practice to

avoid contact with chemicals by wearing suitable gloves when handling.

Respiratory

Protection from inhalation is not normally necessary. If ventilation is

inadequate or dust is likely to build up then use of a suitable dust mask

would be appropriate.

Appearance

Round beige quarter scored tablets.

Odour

Typical penicillin odour.

No data available.

Vapour pressure

No data available.

Boiling point/range

No data available.

Freezing/Melting point

No data available.

Solubility

No data available.

Specific gravity/density

No data available.

Flash Points

No data available.

Flammable limits (in air)

No data available.

Ignition temperature

No data available.

2 of 4

MSDS|Amoxyclav 50, 200, 250 and 500 Broadspectrum Antibiotic Tablets

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/4/Amoxyclav+50%2C+200%2C+250+and+500+Broadspectrum+Antibiotic+Tablets/pdf

Copyright © 2005 Apex Laboratories Pty. Ltd. All rights reserved.

SECTION VI Accidental Release Measures

SECTION VII Handling and Storage

SECTION VIII Exposure Controls and Personal Protection

SECTION IX Physical and Chemical Properties

Chemical stability

This mixture is stable under normal ambient and anticipated storage and

handling conditions of temperature and pressure.

Conditions to avoid

Avoid excessive humidity and keep under 25oC.

Incompatible materials

Oxidising agents.

Decomposition products

Amoxycillin trihydrate (active ingredient) can emit toxic fumes under fire

conditions.

Hazardous reactions

Hazardous polymerisation will not occur with amoxycillin.

Handling of the formulated product is not expected to cause any adverse affects. The following data pertains

particularly to the active and any hazardous ingredients in the formulation, rather than this specific formulation.

Acute Health Effects

Ingestion

Eye contact is not a great risk as this product is a tablet. The data

available suggests that this product may cause a transient irritation that is

unlikely to be anything more than mildly uncomfortable. This effect should

disappear when the product is removed.

Skin

Skin contact is not a great risk as this product is a tablet. The data

available suggests that this product is not harmful. Allergic skin reactions

may develop in sensitive individuals.

Inhalation

Inhalation is not a great risk as this product is a tablet. The data available

suggests that this product will not harm the respiratory system if inhaled.

Allergic reactions can result in sensitive individuals following inhalation.

Chronic Health Effects

Ingestion

Repeated ingestion of penicillin products may cause vomiting and or

nausea, diarrhoea, sore and dry throat, sore and black hairy tongue.

Some bacterial may develop resistance to this antibiotic with chronic

exposure and there is risk of superinfection due to overgrowth of non-

susceptible organisms.

There is no data available on the long term effects of eye contamination

with this product.

Skin

The data available suggests that chronic skin contact may lead to

sensitisation.

Inhalation

The data available suggests that chronic inhalation may lead to

sensitisation.

Advice to Doctor

Treatment for any adverse effects should be symptomatic. Amoxycillin is

widely distributed in body fluids and tissues including pleural, pericardial,

peritoneal and synovial fluid. It also crosses the placenta. The blood

brain barrier is only significantly crossed in the presence of inflammation.

Skin reactions usually spontaneously resolve within a few days of

withdrawal of amoxycillin. Antihistamines with or without corticosteroids

may alleviate symptoms. If serious analphylactoid reactions occur,

treatment including adrenalin, oxygen, intravenous corticosteroids and

endotracheal intubation may be required.

Carcinogenicity

No ingredient in this formulation is known to be carcinogenic.

Compounding effects

Amoxycillin is secreted in breast milk.

Ecotoxicity

No data available.

Persistence and Degradability

No data available.

Mobility

No data available.

3 of 4

MSDS|Amoxyclav 50, 200, 250 and 500 Broadspectrum Antibiotic Tablets

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/4/Amoxyclav+50%2C+200%2C+250+and+500+Broadspectrum+Antibiotic+Tablets/pdf

Copyright © 2005 Apex Laboratories Pty. Ltd. All rights reserved.

SECTION IX Physical and Chemical Properties

SECTION XI Toxicological Information

SECTION XII Ecological Information

Disposal Methods

Empty containers may be recycled or sent to a commercial waste disposal

site. Unused product should be suitable for landfill however contact the

relevant local Waste Disposal Authority.

Special Precautions

Do not dispose into sewers or waterways.

UN Number

None allocated.

UN Shipping Name

None allocated.

ADG Class

None allocated

Packing Group

None allocated.

Special Precautions

None allocated.

Hazchem Code

None allocated

Poisons Schedule

Date

This MSDS has been reviewed and updated as required in May 2009.

NOHSC: National Occupational Health and Safety Commission

ADG Class: Australian Dangerous Goods Class

CAS Number: Chemical Abstracts Service Number

TWA: Time Weighted Average

STEL: Short Term Exposure Limit

UN: United Nations

Disclaimer

This Material Safety Data Sheet has been developed according to WORKSAFE Australia, NOHSC Guidelines.

Hazard Classifications have been determined in consultation with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(1999)].

However, to the best of our knowledge, the finished product is unlikely to cause harm to humans handling, administering and dispensing as per label

instructions.

The data, information and recommendations herein are represented in good faith and are believed to be correct as of the date hereof.

The purpose of this Material Safety Data Sheet is to describe products in terms of their safety requirements.

Apex Laboratories Pty Ltd make no representation of merchantability, fitness for a particular purpose or application, or of any other nature with respect to the

information or the product to which the information refers ("the product").

The information is supplied upon the condition that the persons receiving same will make their own determination as to its suitability prior to use of the product.

The physical data shown herein are typical values based on material tested. These values should not be construed as guaranteed analysis of any specific lot

or as guaranteed specification for the product or specific lots hereof.

Due care should be taken to make sure that the use or disposal of this product and/or its packaging is in compliance with relevant Federal, State and Local

Government Regulations.

4 of 4

MSDS|Amoxyclav 50, 200, 250 and 500 Broadspectrum Antibiotic Tablets

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/4/Amoxyclav+50%2C+200%2C+250+and+500+Broadspectrum+Antibiotic+Tablets/pdf

Copyright © 2005 Apex Laboratories Pty. Ltd. All rights reserved.

SECTION XIIIDisposal Considerations

SECTION XIV Transport Information

SECTION XV Regulatory Information

SECTION XVI Other Information

Key to Abbreviations

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