TERRAMYCIN 100 INJECTABLE SOLUTION

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

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Active ingredient:
OXYTETRACYCLINE HYDROCHLORIDE
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
oxytetracycline HCl(100mg/mL)
Pharmaceutical form:
PARENTERAL LIQUID/SOLUTION/SUSPENSION
Composition:
OXYTETRACYCLINE HYDROCHLORIDE ANTIBIOTIC Active 100.0 mg/ml
Units in package:
100mL; 250mL
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
CATTLE | HORSE | PIGS | SHEEP | BEEF | BOAR | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COLT | COW |
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
ANTIBIOTIC - ANTI-INFECTIVE | ABRASIONS | ABSCESSES | AIRSACCULITIS | ANTISEPTIC | AVIAN MYCOPLASMAS | BLACKHEAD | BODY ODOURS | BOWED TENDONS | BROAD SPECTRUM | BURNS | COCCIDIOSIS | COLIFORM COMPLEX | CONJUNCTIVITIS | COWPOX | CRACKS | CRUSTS | DANDRUFF | DERMATOLOGICAL DISORDERS | DERMATOSIS | DRY SKIN | DYSENTERY | ECZEMA | ENDOMETRITIS | ENTERIC DISEASES | ENZOOTIC PNEUMONIA | FEED EFFICIENCY | FUNGAL INFECTIONS | GIRTH GALLS | INFECTIONS | INFLAMMED PADS | ITCHING | KERATOLYTIC | LACERATIONS | MASTITIS | MYCOPLASMAS | ODOURS | OPEN WOUNDS | OTITIS | PRURITIS | QUEENSLAND ITCH | RESPIRATORY DISEASE | SADDLE RASH | SALMONELLOSIS | SCABS | SCALY SKIN | SHEATH ROT | SKIN IRRITATIONS | SORES | SWINE DYSENTERY | TEAT CRACKING | TEAT INFECTIONS | TOPICAL INFECTIONS | UDDER SORES | WEIGHT GAIN | WIRE CUTS | WOUNDS
Product summary:
Poison schedule: 4; Withholding period: WHP: MEAT: Do not use less than 14 days before slaughter for human consumption . MILK: Milk taken from animals within 7 days following last treatment must no t be used for human consumption or sup plied for processing. This milk should not be fed to bobby calves. HORSES: Me at withholding period 28 days. TRADE AD VICE: EXPORT SLAUGHTER INTERVAL(ESI):Th is product does not have an ESI establi shed For advice on the ESI,contact the manufacturer on 1800 814 883 before us ing this product.; Host/pest details: CATTLE: [ANTIBIOTIC - ANTI-INFECTIVE]; HORSE: [ANTIBIOTIC - ANTI-INFECTIVE]; PIGS: [ANTIBIOTIC - ANTI-INFECTIVE]; SHEEP: [ANTIBIOTIC - ANTI-INFECTIVE]; Poison schedule: 4; Withholding period: ; Host/pest details: CATTLE: [ANTIBIOTIC - ANTI-INFECTIVE]; HORSE: [ANTIBIOTIC - ANTI-INFECTIVE]; PIGS: [ANTIBIOTIC - ANTI-INFECTIVE]; SHEEP: [ANTIBIOTIC - ANTI-INFECTIVE]; Broad spectrum antibiotic for horses, cattle, sheep and pigs.See Precautions, etc. on label
Authorization status:
Registered
Authorization number:
48509
Authorization date:
2020-07-01

Info

pest

Verified

Product Name: Terramycin

100 Injectable

Page: 1 of 5

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

Section 1 - Identification of Chemical Product and Company

Pfizer Australia Pty Ltd

38-42 Wharf Road

West Ryde NSW 2114

Tel: (02) 9850 3333

Fax: (02) 9850 3399

____________________________________

Pfizer Australia Pty Ltd

A.B.N. 50 008 422 348

Substance:

Antibiotic formulation.

Trade Name:

Terramycin

®

100 Injectable

Product Code:

10-MI-179

Pfizer MSDS Code:

MSDS006

Product Use:

Treatment of diseases due to oxytetracycline sensitive organisms in horses, cows,

sheep and pigs.

Creation Date:

March, 2003

This version issued:

April, 2010

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 Australia.

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

Risk Phrases:

Not Hazardous - No criteria found.

Safety Phrases:

Not Hazardous - No criteria found.

SUSDP Classification:

ADG Classification:

None allocated. Not a Dangerous Good.

UN Number:

None allocated

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Physical Description & colour

: Clear yellowish-brown solution.

Odour:

No specific odour.

Major Health Hazards:

no significant risk factors have been found for this product.

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Inhalation

Short term exposure:

Available data indicates that this product is not harmful. In addition product is unlikely to

cause any discomfort or irritation.

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. In addition product is unlikely to cause any discomfort in normal use.

Long Term exposure:

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

Eye Contact:

Short term exposure

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

irritating to eyes, but is unlikely to cause anything more than mild discomfort which should disappear once product is

removed.

Long Term exposure

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

Ingestion:

Short term exposure

: Available data shows that this product is not harmful. This product is unlikely to cause any

irritation problems in the short or long term.

Product Name: Terramycin

100 Injectable

Page: 2 of 5

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

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:

Povidone is Class 3 - unclassifiable as to carcinogenicity to humans.

Section 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

3

)

STEL (mg/m

3

)

Oxytetracycline hydrochloride

2058-46-0

not set

not set

Povidone (Polyvinylpyrrolidone)

9003-39-8

>10

not set

not set

Other non hazardous ingredients

secret

<10

not set

not set

Water

7732-18-5

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 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 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. 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.

Accidental self-injection

: If possible the application of gentle squeezing pressure with absorbent material (e.g.

facial tissue) at the injection site will swab up unabsorbed material. Strong squeezing of the site should be avoided.

The damaged area should be thoroughly cleansed and a topical antiseptic applied.

Inhalation:

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

Skin Contact:

No specific health data is available for this product. If any unusual symptoms become evident, or if in

doubt, contact a Poisons Information Centre or a doctor.

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.

Ingestion:

First aid is not generally required. 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.

Fire decomposition products from this product may be toxic if inhaled. Take appropriate protective measures.

This product is likely to decompose only after heating to dryness, followed by further strong heating.

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:

Does not burn.

Flammability Class:

Does not burn.

Section 6 - Accidental Release Measures

Accidental release

: In the event of a major spill, prevent spillage from entering drains or water courses. As a

minimum, wear overalls, goggles and gloves. Suitable materials for protective clothing include rubber. Stop leak if

safe to do so, and contain spill. Absorb onto sand, vermiculite or other suitable absorbent material. If spill is too large

or if absorbent material is not available, try to create a dike to stop material spreading or going into drains or

waterways. Sweep up and shovel or collect recoverable product into labelled containers for recycling or salvage, and

Product Name: Terramycin

100 Injectable

Page: 3 of 5

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

dispose of promptly. Recycle containers wherever possible after careful cleaning. After spills, wash area preventing

runoff from entering drains. If a significant quantity of material enters drains, advise emergency services. This material

may be suitable for approved landfill. Ensure legality of disposal by consulting regulations prior to disposal.

Thoroughly launder protective clothing before storage or re-use. Advise laundry of nature of contamination when

sending contaminated clothing to laundry.

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 class of poison. Store packages of this product in a cool place. Make sure that the product does not come into

contact with substances listed under "Materials to avoid" 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.

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 Oxytetracycline is set at 0.03mg/kg/day. ADI means Acceptable Daily Intake and NOEL means No-

observable-effect-level. Values taken from Australian ADI List, April 2008.

Ventilation:

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

the work environment remains clean and that dusts are minimised.

Eye Protection:

Eye protection is not normally necessary when this product is being used. However, if in doubt,

wear suitable protective glasses or goggles.

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 handling this product.

Protective Material Types:

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

Respirator:

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

the Australian Standard mentioned above.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

Clear yellowish-brown solution.

Odour:

No specific odour.

Boiling Point:

Approximately 100°C at 100kPa.

Freezing/Melting Point:

Approximately 0°C.

Volatiles:

Water component.

Vapour Pressure:

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

Vapour Density:

No data.

Specific Gravity:

1.085-1.095 at 25°C

Water Solubility:

Completely soluble in water.

pH:

pH (10% aqueous solution) is adjusted to range 8.3-8.8 during manufacture.

Volatility:

No data.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water distribution

No data

Viscosity:

<45cS at 25 °C

Autoignition temp:

Does not burn.

Product Name: Terramycin

100 Injectable

Page: 4 of 5

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

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:

None known. Refrigerate, preferably between 2 and 8°C, but do not freeze.

Incompatibilities:

strong acids, strong bases, strong oxidising agents.

Fire Decomposition:

Carbon dioxide, and if combustion is incomplete, carbon monoxide and smoke. Hydrogen

chloride gas, other compounds of chlorine. 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 is unlikely to undergo polymerisation processes.

Section 11 - Toxicological Information

Target Organs:

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

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Ingredient

Risk Phrases

No hazardous ingredients present in hazardous concentrations.

Oncogenicity: Oxytetracycline hydrochloride oncogenicity data indicates equivocal evidence of oncogenicity in male

and female rats. The EPA (USA) concludes that, although the findings were termed "equivocal" by the National

Toxicology Program, they do not represent positive evidence of carcinogenicity in the rat. A similar study in mice

indicated no evidence of oncogenicity.

Teratogenicity: Female Charles River CD rats were dosed during days 6 through 15 of gestation with 1200, 1350, or

1500 mg/kg of Oxytetracycline hydrochloride. There were dose-related decreases in maternal survival and body

weight gain, and increases in the incidence of respiratory difficulties and rough coat. In addition, there were significant

dose- related decreases in the percent of treated dams found pregnant. There was also a dose-related decrease in

foetal body weight. The high incidence of maternal deaths and the foetotoxicity noted in all dose levels tested did not

allow for an establishment of a NOEL. The LEL was 1200 mg/kg/day (lowest dose tested). The significant findings

discussed in this study can be attributed to the excessive dose levels used, and the overly stressing of the treated

dams.

Section 12 - Ecological Information

This product is biodegradable. It will not accumulate in the soil or water or cause long term problems.

Section 13 - Disposal Considerations

Disposal:

Containers should be emptied as completely as practical before disposal. If possible, recycle containers

either in-house or send to recycle company. If this is not practical, send to a commercial waste disposal site. This

product should be suitable for landfill. However, check with local Waste Disposal Authority before sending there. Note

that product properties may have been changed in use, significantly altering it's suitability for landfill. Please do NOT

dispose into sewers or waterways.

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 to be found in the public AICS Database.

The following ingredient: Oxytetracycline is found 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

Product Name: Terramycin

100 Injectable

Page: 5 of 5

This revision issued: April, 2010

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: (02)9850 3333

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

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

Contact Points:

Pfizer

(02)9850 3333 (Business hours)

Ask for Environmental Health & Safety Manager

Police and Fire Brigade:

Dial 000

If ineffective:

Dial Poisons Information Centre

(

13 1126 from anywhere in Australia)

Please read all labels carefully before using product.

This MSDS copyright © Kilford & Kilford Pty Ltd, April, 2010.

http://www.kilford.com.au/ Phone (02)9251 4532

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