MOXYLAN 50MG TABLETS BROAD SPECTRUM ANTIBIOTIC

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

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Active ingredient:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE
Available from:
Jurox Pty Limited
INN (International Name):
amoxycillin as trihydrate(50mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
AMOXYCILLIN AS AMOXYCILLIN TRIHYDRATE ANTIBIOTIC Active 50.0 mg/Tb
Units in package:
500 Tabs
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 the treatment of infections caused by amoxycillin susceptible organisms in dogs and cats.Do not administer to small herbivores or animals with a history of allergic reaction to penicillins.
Authorization status:
Registered
Authorization number:
50605
Authorization date:
2019-07-01

I:\prodDocs\make into pdf\50605_0898c.doc

08/01/2001

Moxylan 50mg Tablets label 25/2/98

page 1/1

PANEL 1

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

MOXYLAN

50mg TABLETS

Broad Spectrum Antibiotic

50mg per tablet AMOXYCILLIN as the Trihydrate

For the treatment of infections caused by amoxycillin susceptible organisms

in dogs and cats.

Jurox

500 tablets

PANEL 2

DIRECTIONS FOR USE:

Do not administer to small herbivores or animals with a history of

allergic reaction to penicillins.

Dose: 4-11 mg/kg body weight twice daily until 48 hours after symptoms have

subsided.

For oral administration only.

Prescription Animal Remedy (P.A.R) Class 1, for use only following a

veterinary consultation.

Licensed under the Animal Remedies Act 1967, No.

Licensed to Jurox New Zealand Limited

51 Shortland St, Auckland, ph/fax 09 236 3915

Made in Australia

Jurox Pty Ltd

85 Gardiners Rd

Rutherford NSW 2320

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

Store below 25

C (Air Conditioning) in a dry place.

Exp:

NRA 50605/0898

Info

pest

Verified

MOXYLAN TABLETS

Page 1 of 5

continued

ISSUED:

28 August 2012

SAFETY DATA SHEET

Section 1: IDENTIFICATION of CHEMICAL PRODUCT and COMPANY

Product Name:

Moxylan Tablets

Product Code:

501620 (50mg), 501655 (200mg)

Recommended Use:

For the treatment of amoxicillin susceptible bacterial infections in dogs and

cats.

Company Identification:

Jurox Pty Limited

Address:

85 Gardiner Street

Rutherford NSW 2320

Australia

Customer Centre:

1800 023 312

National Poisons Information Centre:

131126 (Australia-wide)

Emergency Telephone Number:

1800 023 312 (9a.m. – 5p.m.)

Section 2: HAZARDS IDENTIFICATION

1

GHS Hazard Classifications:

Eye Irritation Category 2B

Respiratory Sensitizer Category 1

Skin Sensitizer Category 1

STOT – SE Category 3

GHS Pictograms:

Exclamation mark

Health hazard

Signal Word:

Danger

Hazard Statements:

H317

May cause an allergic skin reaction.

H320

Causes eye irritation.

H334

May cause allergy or asthma symptoms or breathing difficulties if inhaled.

H335

May cause respiratory irritation.

Precautionary Statements:

Prevention

P261

Avoid breathing dust and vapours from reconstituted product.

P264

Wash hands thoroughly after handling.

P271

Use only outdoors or in a well-ventilated area.

P272

Contaminated work clothing should not be allowed out of the workplace.

P280

Wear protective gloves e.g. PVC or vinyl and protective eyewear e.g. Safety

glasses with eye side shields or chemical goggles.

P285

In case of inadequate ventilation wear respiratory protection.

Response

P302+P352

IF ON SKIN: Wash with plenty of soap and water.

P304+P341

IF INHALED: If breathing is difficult, remove victim to fresh air and

keep at rest in a position comfortable for breathing.

P305+P351

IF IN EYES: Rinse cautiously with water for several minutes.

+P338

Remove contact lenses, if present and easy to do. Continue rinsing.

N.B.: These statements are determined by Work Health and Safety regulations and may not reflect Signal Headings and

First Aid and Safety statements on product labelling, which are determined by a competent authority during assessment

for registration.

MOXYLAN TABLETS

Page 2 of 5

continued

P312

Call a POISON CENTRE or doctor if you feel unwell.

P333+P313

If skin irritation or rash occurs: Get medical advice.

P337+P313

If eye irritation persists: Get medical advice/attention.

P342+P311

If experiencing respiratory symptoms: Call a POISON CENTER or

doctor.

P363

Wash contaminated clothing before reuse.

Storage

P403+P233

Store in a well-ventilated place. Keep container tightly closed.

P405

Keep locked up.

Disposal

P501

Dispose of contents/container in accordance with local/national

regulations.

Section 3: COMPOSITION / INFORMATION on INGREDIENTS

INGREDIENT

CAS No.

CONTENT

Cellulose

9004-34-6

>60%

Amoxycillin trihydrate

26787-78-0

38 %

Section 4: FIRST AID MEASURES

First Aid Measures:

Consult the National Poisons Centre on 131126 or a doctor immediately in every case of

suspected chemical poisoning. Never give fluids or induce vomiting if a patient is unconscious

or convulsing regardless of cause of injury. If medical advice/attention is needed, have product

container or label at hand.

Inhalation:

If fumes, aerosols or combustion products are inhaled remove from contaminated area. Other

measures are usually not necessary.

Ingestion:

Sensitive individuals who have been exposed to penicillin antibiotics might exhibit allergic

reactions, possibly life threatening. If swallowed, immediately give a glass of water. First aid is

not generally required. If in doubt, contact a Poisons Information Centre of a doctor.

Skin:

Mild irritant. May cause skin rashes in sensitised persons. If skin contact occurs, immediately

remove all contaminated clothing, including footwear. Wash affected area thoroughly with

plenty of soap and water. If skin irritation or rash occurs, get medical advice/attention.

Eye:

Mild to moderate irritant. If eye contact occurs, rinse cautiously with water for at least 20

minutes. If eye irritation persists, get medical advice/attention.

Advice to Doctor:

Treat as an overdose of penicillin antibiotics.

Flash Point:

Not flammable.

Hazardous Combustion

If involved in a fire, may emit noxious fumes. Non-combustible – not considered to be a

Products:

significant fire risk.

Extinguishing Media:

There is no restriction on the type of extinguisher which may be used. Use extinguishing media

suitable for surrounding area.

Protective Equipment:

Protective gloves and boots and breathing apparatus

Section 5: FIRE FIGHTING MEASURES

MOXYLAN TABLETS

Page 3 of 5

continued

Spills and Disposal:

Wear appropriate protective clothing. Exclude non-essential people from the area. Contain

spill and sweep up / absorb with inert material such as soil, sand or absorbent granules and

place in a sealable waste container. Ventilate area and wash spill site after pick-up complete.

Dispose of waste safely.

Protective Clothing:

For appropriate personal protective equipment see section 8.

Environmental

If contamination of drains and waterways occurs, advise Emergency Services.

Precautions:

Handling:

Avoid contact with skin and eyes. Use personal protective equipment as required.

Storage:

Store in original container, away from foodstuffs. Store below 25

C. (air conditioning) in a dry

place.

Other Information:

Always read the label before use. See label for further information on handling and storage.

This MSDS describes personal protective measures relating to long term industrial and

manufacturing exposure and emergency situations, such as accidents and spills. See product label

for personal protective measures during normal use of the marketed product.

Exposure Limits:

No exposure limits have been assigned for this product. Do not handle until all safety

precautions have been read and understood.

Protective Equipment:

Safety glasses with eye side shields or chemical goggles. Chemical protective gloves, e.g.

PVC. Safety footwear or safety gumboots, e.g. rubber.

Engineering Controls:

Handle in a well ventilated area.

Hygiene Precautions:

Do not drink, eat or smoke when handling this product. Wash hands after use.

Appearance:

A speckled, off-white circular

tablet.

Odour:

Not available.

Odour threshold:

Not available.

pH:

Not available.

Melting Point:

Not available.

Boiling Point:

Not available.

Flash Point:

Not flammable.

Evaporation Rate:

Not available.

Flammability:

Not applicable.

Upper flammability

limits:

Not applicable.

Lower flammability

limits:

Not applicable.

Vapour Pressure:

Not available.

Vapour density:

Not available.

Relative density:

Not available.

Specific Gravity:

Not available.

Solubility in Water:

Insoluble - disintegrates.

Partition coefficient:

Not available.

Auto-ignition

temperature:

Not available.

Decomposition

temperature:

Not available.

Viscosity:

Not applicable.

Section 6: ACCIDENTAL RELEASE MEASURES

Section 7: HANDLING AND STORAGE

Section 8: EXPOSURE CONTROLS/PERSONAL PROTECTION

Section 9: PHYSICAL AND CHEMICAL PROPERTIES

MOXYLAN TABLETS

Page 4 of 5

continued

Stability:

When stored appropriately this product should show no significant degradation for at least

30 months from the date of manufacture.

Hazardous

Not known to occur.

Polymerisation:

Materials to Avoid:

None known.

Ingestion:

May produce nausea and vomiting. Not classified as acutely toxic.

Amoxycillin:

(oral): 15000 mg / kg (rat)

(oral): 25000 mg / kg (mouse)

Skin:

Causes mild skin irritation.

REMARK: Amoxycillin is a penicillin and the most important adverse reaction is

hypersensitivity.

Eye:

Causes eye irritation.

REMARK: Amoxycillin is a penicillin and the most important adverse reaction is

hypersensitivity.

Chronic Effects:

May cause allergic reactions, possibly serious in sensitised individuals. Repeated ingestion of

penicillins can cause nausea and/or vomiting, stomach upset, diarrhoea, sore or dry throat,

and a sore or black hairy tongue.

Mutagenicity:

Not known to be a mutagen.

Carcinogenicity:

Not known to be carcinogenic.

Reproductive Toxicity:

Not known to cause reproductive toxicity.

STOT:

Not known to cause damage to specific organs.

Aspiration hazard:

REMARK: Amoxycillin is a penicillin and the most important adverse reaction is

hypersensitivity.

Ecotoxicity:

Ingredient

Persistence:

Water/Soil

Persistence:

Air

Bioaccumulation

Mobility

Cellulose

No data

available

HIGH

Amoxycillin

trihydrate

HIGH

No data

available

Product Disposal:

Dispose of product only by using according to label or by approved waste collection.

Container Disposal:

Wrap with paper and place in garbage.

Dangerous Goods

Not classified as a Dangerous Good according to the criteria of the Australian Dangerous

Classification:

Goods (ADG) Code.

HAZCHEM Code:

None specified

Section 10: STABILITY AND REACTIVITY

Section 11: TOXICOLOGICAL INFORMATION

Section 12: ECOLOGICAL INFORMATION

Section 13: DISPOSAL INFORMATION

Section 14: TRANSPORT INFORMATION

MOXYLAN TABLETS

Page 5 of 5

Poisons Schedule:

APVMA Registration No:

50605 (50 mg) and 50606 (200 mg)

This information is based on data believed by Jurox Pty Limited to be accurate at the time of writing but is subject to change without notice. It is given

in good faith, but no warranty expressed or implied is made as to its accuracy, completeness otherwise and no assumption of liability from howsoever

arising is made by Jurox Pty Limited by reason of the provision of this information. Every person dealing with the materials referred to herein does so

at his/her own risk absolutely and must make independent determinations of suitability and completeness of information from all sources to ensure

their proper use.

This SDS supercedes the version created on 1 October 2003 and updates the format as per the Code of Practice on

Preparation of Safety Data Sheets for Hazardous Chemicals, December 2011, published by Safe Work Australia.

Legend

CAS No. means a unique number assigned to a chemical by the Chemical Abstracts Service.

GHS means the ‘Globally Harmonized System of Classification and Labelling of Chemicals, 3

rd

Revised Edition’,

published by the United Nations.

LD

50

means the median lethal dose, which represents the single dose of a substance that can be expected to cause death

in 50% of animals.

PVC means Polyvinyl chloride.

STOT - SE means Specific Target Organ Toxicity – Single Exposure.

References

ChemID PlusLite, http://chem.sis.nlm.nih.gov/chemidplus/chemidlite.jsp, entry for Amoxicillin anhydrous

(RN: 26787-78-0).

New Zealand Environmental Protection Authority, HSNO Chemical Classification and Information Database (CCID), entry

for Amoxycillin trihydrate (Cas Number: 61336-70-7).

THE VSDB (Veterinary Substances Database, http://sitem.herts.ac.uk/aeru/vsdb/, entry for amoxicillin.

END OF SDS

Section 15: REGULATORY INFORMATION

Section 16: OTHER INFORMATION

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