LINCOMIX 800 ANTIBIOTIC SOLUBLE POWDER

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

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Active ingredient:
LINCOMYCIN AS LINCOMYCIN HYDROCHLORIDE
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
lincomycin as HCl(800mg/g)
Pharmaceutical form:
ORAL POWDER, PRE-MIX
Composition:
LINCOMYCIN AS LINCOMYCIN HYDROCHLORIDE ANTIBIOTIC Active 800.0 mg/g
Units in package:
5kg
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
PIGS | BOAR | GILT | PIGLET | SOW | SWINE
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
SWINE DYSENTERY
Product summary:
Poison schedule: 4; Withholding period: WHP: Meat: Remove all medicated water two days before slaughter for human con sumption. TRADE ADVICE: EXPORT SLAUGHT ER INTERVAL (ESI): This product does no t have an ESI established.; Host/pest details: PIGS: [SWINE DYSENTERY]; For the treatment of swine dysentery caused by Serpulina hyodysenteriae in pigs.Do not allow rabbits, hamsters, guinea pigs, horses or ruminants access to water containing lincomycin.
Authorization status:
Registered
Authorization number:
51987
Authorization date:
2020-07-01

PFIZER ANIMAL HEALTH

Product Name: LINCOMIX

800 ANTIBIOTIC SOLUBLE POWDER

Date: 24 August 2010

Page 1 of 3

Product Size: 5kg

Description: Immediate Label

File number: 51987_50075_5kg_immediate_MPL_V01.doc

Version: May 2010

Text above this line and in italics between parallel lines is not included in the label copy.

IMMEDIATE CONTAINER - Main Panel

PRESCRIPTION ANIMAL REMEDY

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

Lincomix

®

800

Antibiotic Soluble Powder

LINCOMYCIN...........................800mg/g

(as lincomycin hydrochloride)

For the treatment of swine dysentery caused by Serpulina hyodysenteriae in pigs.

5 kg

CODES

Animal Health

A division of Pfizer Australia Pty Ltd

38-42 Wharf Road

West Ryde NSW 2114

RLP

APPROVED

Info

pest

Verified

PFIZER ANIMAL HEALTH

Product Name: LINCOMIX

800 ANTIBIOTIC SOLUBLE POWDER

Date: 24 August 2010

Page 2 of 3

Product Size: 5kg

Description: Immediate Label

File number: 51987_50075_5kg_immediate_MPL_V01.doc

Version: May 2010

Text above this line and in italics between parallel lines is not included in the label copy.

IMMEDIATE CONTAINER – Left Panel

DIRECTIONS FOR USE:

Precautions

Do not allow rabbits, hamsters, guinea pigs, horses, or ruminants access to water containing

lincomycin. Ingestion by these species may result in severe gastrointestinal effects.

Do not use the water treatment and the feed treatment simultaneously.

Monitor water consumption carefully. Factors such as diet, ambient temperature, humidity

and severity of disease will cause variable fluid intake. Consumption is greater during

warmer temperatures.

Excessive dosage may lead to an increased incidence of side effects which may include

rectal prolapse.

Side Effects

Loosening of faeces and/or mild swelling and irritation of the anus and/or vulva have been

observed occasionally within the first two days after the onset of treatment in swine. This

usually is transient. On rare occasions, some pigs may develop reddening of the skin and

irritable behaviour. The signs diminish usually within 5 to 8 days without discontinuing the

therapy.

BARCODE

IMMEDIATE CONTAINER – Right Panel

DOSAGE AND ADMINISTRATION:

Administer in drinking water at a concentration of 33mg lincomycin/L.

Dissolve 21g (

4 rounded scoops) of Lincomix

800 in 10L water. This solution should then be

added to 500L of drinking water.

Use medicated drinking water as the only source of drinking water available to the pigs during

the period of treatment.

Discard medicated drinking water if not used within 2 days. Medicate water for 5 days after the

disappearance of bloody stools, or for a maximum of 10 consecutive days.

WITHHOLDING PERIOD:

MEAT: REMOVE ALL MEDICATED WATER TWO days before slaughter for human

consumption.

PFIZER ANIMAL HEALTH

Product Name: LINCOMIX

800 ANTIBIOTIC SOLUBLE POWDER

Date: 24 August 2010

Page 3 of 3

Product Size: 5kg

Description: Immediate Label

File number: 51987_50075_5kg_immediate_MPL_V01.doc

Version: May 2010

Text above this line and in italics between parallel lines is not included in the label copy.

TRADE ADVICE: EXPORT SLAUGHTER INTERVAL (ESI): This product does not have an

ESI established. For advice on the ESI, contact the manufacturer on 1800 814 883 before

using this product.

FIRST AID: If poisoning occurs contact a doctor or Poisons Information Centre. Phone

Australia 131 126.

Disposal

Rinse into the medicated water. Do not dispose of undiluted chemicals on site.

Break, crush or puncture and bury empty containers in a local authority landfill. If no landfill is

available, bury the containers below 500mm in a disposal pit specifically marked and set up for

this purpose clear of waterways, vegetation and roots. Empty containers and product should

not be burnt.

APVMA Approval No. 51987/50075

Store below 30°C (Room Temperature). Protect from moisture.

Batch Number:

Expiry Date:

Product Name: LINCOMIX® 800 Antibiotic Soluble Powder

Page: 1 of 5

This revision issued: September, 2011

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

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

Section 1 - Identification of The Material and Supplier

Pfizer Australia Pty Ltd

38-42 Wharf Road

West Ryde NSW 2114

Tel: 1800 814 883

Fax: (02) 9850 3399

____________________________________

Pfizer Australia Pty Ltd

A.B.N. 50 008 422 348

Chemical nature:

Lincomycin is an antibiotic substance.

Trade Name:

LINCOMIX® 800 Antibiotic Soluble Powder

Product Use:

Antibiotic.

Creation Date:

January, 2005

This version issued:

September, 2011

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.

SUSMP Classification:

ADG Classification:

None allocated. Not a Dangerous Good.

UN Number:

None allocated

Emergency Overview

Physical Description & colour

: White to off white coloured powder.

Odour:

Slight fermentation or “dead mouse” odour.

Major Health Hazards:

no significant risk factors have been found for this product.

Potential Health Effects

Repeated overexposure to lincomycin may cause abdominal cramps, diarrhoea and colitis. This may begin several

weeks after exposure has ceased. Some hematopoietic effects have been reported with the use of lincomycin.

Hypersensitivity reactions have been reported in people known to be sensitive to penicillin. Rare instances of

erythema multiforme, some resembling Stevens-Johnsone Syndrome, have been associated with lincomycin

hydrochloride.

Inhalation

Short term exposure:

Significant inhalation exposure is considered to be unlikely. Long term inhalation of high

amounts of any nuisance dust may overload lung clearance mechanism. 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. 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

: Exposure via eyes is considered to be unlikely. This 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:

Product Name: LINCOMIX® 800 Antibiotic Soluble Powder

Page: 2 of 5

This revision issued: September, 2011

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

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

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.

Section 3 - Composition/Information on Ingredients

Ingredients

CAS No

Conc,%

TWA (mg/m

STEL (mg/m

Lincomycin hydrochloride monohydrate

7179-49-9

800g/kg

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 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.

Treat hypersensitivity reactions as indicated clinically. Lincomycin has been shown to have neuromuscular blocking

properties that may enhance the action of other neuromuscular-blocking agents. if an allergic reaction

should occur, the usual agents (epinephrine, corticosteroids, antihistamines) should be used as indicated.

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. If in doubt obtain medical advice.

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.

Ingestion:

If product is swallowed or gets in mouth, 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.

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

: 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, PVC. If there is

a significant chance that dusts are likely to build up in cleanup area, we recommend that you use a suitable Dust

Mask.

Stop leak if safe to do so, and contain spill. Sweep up and shovel or collect recoverable product into labelled

containers for recycling or salvage, and dispose of promptly. Consider vacuuming if appropriate. 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.

Product Name: LINCOMIX® 800 Antibiotic Soluble Powder

Page: 3 of 5

This revision issued: September, 2011

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

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

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 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.

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, Occupational Protective Clothing: AS/NZS 4501

set 2008, 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 Lincomycin is set at 1mg/kg/day. The corresponding NOEL is set at 100mg/kg/day. ADI means

Acceptable Daily Intake and NOEL means No-observable-effect-level. Values taken from Australian ADI List, March

2010.

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 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 when skin contact is likely.

Protective Material Types:

There is no specific recommendation for any particular protective material type.

Respirator:

If there is a significant chance that dusts are likely to build up in the area where this product is being

used, we recommend that you use a suitable Dust Mask.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

White to off white coloured powder.

Odour:

Slight fermentation or “dead mouse” odour.

Boiling Point:

Not available.

Freezing/Melting Point:

No specific data. Solid at normal temperatures.

Volatiles:

No data.

Vapour Pressure:

No data.

Vapour Density:

No data.

Specific Gravity:

No data.

Water Solubility:

Insoluble.

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:

Store in the closed original container in a dry, cool, well-ventilated area out of direct sunlight.

Product Name: LINCOMIX® 800 Antibiotic Soluble Powder

Page: 4 of 5

This revision issued: September, 2011

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

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

Incompatibilities:

No particular Incompatibilities.

Fire Decomposition:

No specific data. Based on composition of antibiotics, the following might be expected:

Carbon dioxide, and if combustion is incomplete, carbon monoxide and smoke. Nitrogen and its compounds, and

under some circumstances, oxides of nitrogen. Oxides of sulfur (sulfur dioxide is a respiratory hazard) and other sulfur

compounds. 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

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.

Lincomycin hydrochloride: Rat LD

oral 4000mg/kg

subcutaneous 9778mg/kg

intravenous 342mg/kg

Lincomycin hydrochloride: Mouse LD

intraperitoneal 1000mg/kg

intravenous 214mg/kg

Carcinogenicity: Negative

Genotoxicity: Negative

Teratogenicity: No teratogenic effects seen in rats or dogs

Sensitivity: May cause hypersensitivity reactions

Section 12 - Ecological Information

BIODEGRADABILITY:

Lincomycin can be sorbed to soil, but it is readily leached away from soils. Lincomycin is expected to be relatively

mobile and migrate toward the aquatic compartment.

Lincomycin has a low octanol-water partition coefficient at all pH's. The octanol-water partition at pH 7 is 2.550.

Calculated flowing and static bioaccumulation factors are 2.21 and 9.96 respectively. Lincomycin will be expected to

migrate to the aqueous environment, but it should not bioaccumulate in aquatic organisms. Lincomycin will have

some initial inhibitory effects on the most sensitive micro-organisms until it is degraded. Small amounts sent to

sanitary sewage will not adversely effect the abiotic flora of sewage treatment facilities.

PERSISTENCE IN SOIL AND WATER:

Lincomycin bioactivity is readily degraded by mixtures of urine faeces and soil. The half-life of degradation was about

20 days.

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 product are compliant with NICNAS regulations.

The following ingredients: Lincomycin, are mentioned in the SUSMP.

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, 7th Edition

AICS

Australian Inventory of Chemical Substances

CAS number

Chemical Abstracts Service Registry Number

Hazchem Number

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

services especially firefighters

IARC

International Agency for Research on Cancer

Product Name: LINCOMIX® 800 Antibiotic Soluble Powder

Page: 5 of 5

This revision issued: September, 2011

MATERIAL SAFETY DATA SHEET

Issued by: Pfizer Australia Pty Ltd

Phone: 1800 814 883

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

SWA

Safe Work Australia, formerly ASCC and NOHSC

NOS

Not otherwise specified

NTP

National Toxicology Program (USA)

R-Phrase

Risk Phrase

SUSMP

Standard for the Uniform Scheduling of Medicines & Poisons

UN Number

United Nations Number

Contact Points:

Pfizer

1800 814 883

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, September, 2011.

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

MSDS45-VERSION1

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