GROMAX ANTICOCCIDIAL PREMIX

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

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Active ingredient:
MADURAMICIN AMMONIUM; NICARBAZIN
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
maduramicin ammonium(7.5g/kg)+nicarbazin(80g/kg)
Pharmaceutical form:
ORAL POWDER, PRE-MIX
Composition:
MADURAMICIN AMMONIUM ANTIBIOTIC Active 7.5 g/kg; NICARBAZIN UREA Active 80.0 g/kg
Units in package:
20kg; 25kg
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
BROILER
Therapeutic area:
PARASITICIDES
Therapeutic indications:
COCCIDIOSIS - SEE LABEL FOR CAUSES | EIMERIA SPP. | EIMERIA ACERVULINA | EIMERIA ARLOINGI | EIMERIA BOVIS | EIMERIA BRUNETTI | EIMERIA CHRISTENSENI | EIMERIA MAXIMA | EIMERIA MITIS | EIMERIA MIVATI | EIMERIA NECATRIX | EIMERIA NINAKOHLYAKIMOVAE | EIMERIA PRAECOX | EIMERIA TENELLA | EIMERIA ZUERNII
Product summary:
Poison schedule: 5; Withholding period: MEAT: NIL EGGS: Do not use in birds wh ich are producing or may in the future produce eggs or egg products for human consumption. CONSUMPTION.; Host/pest details: BROILER: [COCCIDIOSIS - SEE LABEL FOR CAUSES, EIMERIA SPP.]; For use in broiler chickens for the prevention of coccidiosis caused by Eimeria acervulina, E. maxima and E. tenella and as an aid in the prevention of coccidiosis caused by E. necatrix, E. brunetti and E. mivati.DO NOT USE in birds which are producing or may in the future produce eggs or egg products for human consumption
Authorization status:
Registered
Authorization number:
55130
Authorization date:
2019-07-01

Main

Panel

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS

FOR ANIMAL TREATMENT ONLY

GROMAX®

Page

ANTICOCCIDIAL PREMIX

Active

constituents:

Maduramicin

ammonium

Nicarbazin

g/kg

g/kg

broiler

chickens

prevention

coccidiosis

caused

Eimeria

acervulina

E.

maxima

E.

tene/la

prevention

coccidiosis

caused

E.

necatrix,

E.

brunetti

E.

mivati

DIRECTIONS

USE:

Restraints:

birds

which

producing

future

produce

eggs

products

human

consumption.

Dosage

Administration:

Prepare

blend

order

obtain

more

homogenous

Thoroughly

GROMAX

Anticoccidial

Premix

into

feed

level

tonne

broiler

feed

obtain

concentration

75mg

maduramicin

ammonium/kg

feed

40mg

nicarbazin/kg

feed

prevention

coccidiosis

medicated

feed

containing

GROMAX

should

continuously

broiler

chickens

only

ration

WITHHOLDING

PERIODS:

MEAT:

EGGS:

birds

which

producing

future

produce

eggs

products

human

consumption.

SAFETY

DIRECTIONS:

Poisonous

swallowed.

Will

damage

eyes

irritate

skin.

inhale

dust

when

opening

container

mixing

into

feed

Wear

cotton

overalls

buttoned

neck

wrist,

washable

hat,

elbow

length

gloves

disposable

dust

mask

covering

mouth

nose

After

each

day's

use,

wash

gloves

contaminated

clothing

After

before

eating,

drinking

smoking

wash

hands

arms

face

thoroughly

with

soap

water.

FIRST

AID:

poisoning

occurs,

contact

doctor

Poisons

Information

Centre,

phone

126.

eyes,

hold

eyes

open

flood

with

water

least

minutes

Doctor

Additional

information

listed

Material

Safety

Data

Sheet

(MSDS),

available

from

Phibro

Animal

Health

Disposal:

Shake

empty

contents

into

medicated

feed

dispose

undiluted

chemicals

site

Puncture

bury

empty

containers

local

authority

landfill.

available

bury

containers

below

disposal

specifically

marked

this

purpose

clear

waterways,

vegetation

roots

Empty

containers

product

should

burned.

ALPHARMA

..

Distributed by:

Phibro

Animal

Health Pty

4/129 Magowar Road

Girraween,

2145

Tel:

02 9896 4666

Fax : 02 9896 4544

25

kg

NET

Storage:

Store

below

(room

temperature)

place

Batch

Number:

seal

Expiry

Date:

seal

Gromax is a registered trademark

Alpharma (Luxembourg) S.a.r.

The Alpharma logo

trademark

Alpharma Inc

APVMA

Approval

55130/25kg/061

RLP

APPROVED

Info

pest

Verified

Main

Panel

CAUTION

KEEP OUT OF REACH OF CHILDREN

READ SAFETY DIRECTIONS

FOR ANIMAL TREATMENT ONLY

GROMAX®

Page

ANTICOCCIDIAL PREMIX

Active

constituents:

Maduramicin

ammonium

Nicarbazin

g/kg

80.0

g/kg

broiler

chickens

prevention

coccidiosis

caused

Eimeria

acervulina,

E.

maxima

E.

tenella

prevention

coccidiosis

caused

E.

necatrix,

E.

brunetti

E.

mivati.

DIRECTIONS

USE:

Restraints:

birds

which

producing

future

produce

eggs

products

human

consumption.

Dosage

Administration:

Prepare

pre-blend

order

obtain

more

homogenous

Thoroughly

GROMAX

Anticoccid

Premix

into

feed

level

tonne

broiler

feed

obtain

concentration

75mg

maduramic

ammonium/kg

feed

40mg

nicarbazin/kg

feed.

prevention

coccidiosis,

medicated

feed

containing

GROMAX

should

continuously

broiler

chickens

only

ration.

WITHHOLDING

PERIODS:

MEAT:

EGGS:

birds

which

producing

future

produce

eggs

products

human

consumption.

SAFETY

DIRECTIONS:

Poisonous

swallowed.

Will

damage

eyes

irritate

skin.

inhale

dust

when

opening

conta

mixing

into

feed

Wear

cotton

overalls

buttoned

neck

wrist,

washable

hat,

elbow

length

gloves

disposable

dust

mask

covering

mouth

nose

After

each

day's

use,

wash

gloves

contaminated

clothing

After

before

eating,

drinking

smoking

wash

hands,

arms

face

thoroughly

with

soap

water.

FIRST

poisoning

occurs

contact

doctor

sons

Information

Centre,

phone

eyes,

hold

eyes

open,

flood

with

water

least

minutes

Doctor.

Addit

onal

information

sted

Material

Safety

Data

Sheet

(MSDS),

available

from

Phibro

Health

Disposal:

Shake

empty

contents

into

medicated

feed.

dispose

undiluted

chemicals

site

Puncture

bury

empty

containers

local

authority

landfill.

available

bury

containers

below

disposal

specifically

marked

this

purpose

clear

waterways,

vegetation

roots

Empty

containers

product

should

burned.

ALPHARMA

Distributed by:

Phibro

Animal Health Pty Ltd

4/129 Magowar Road

Girraween,

NSW 2145

9896 4666

Fax :

9896 4544

20

kg

NET

Storage

Store

below

(room

temperature)

place.

Batch

Number:

seal

Expiry

Date

seal

Gromax

a registered trademark

Alpharma (Luxembourg) S.a.r.l.

The Alpharma logo

trademark of Alpharma Inc

APVMA

Approval

55130/20kg/0610

RLP

APPROVED

MSDS Gromax Anticoccidial Premix - Public version

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Section 1: Identification of the Material and Supplier

Product Name: Gromax Anticoccidial Premix

Other Names: Maduramicin mixture.

Proper shipping name (ADG Code): None assigned.

Recommended use: As an anticoccidial premix.

Use as directed.

Supplier: Phibro Animal Health Pty. Ltd.,

ABN: 94 093 869 991

Unit 4, 128 Magowar Road, GIRRAWEEN NSW 2145

Tel: 02 9896 4666 (business hours)

Tel: 0418 213 734 (after hours)

Fax: 02 9896 4544

Emergency Phone Numbers:

Transport/Fire Emergency: 000 (Emergency services)

Medical Emergency: 131126 (Poisons Information Centre)

Section 2: Hazards Identification

Classified as hazardous according to criteria of Worksafe Australia.

Non-dangerous goods.

Risk Phrases: R: 21 Harmful in contact with skin.

Safety Phrases: S: 26 If in eyes, rinse immediately with plenty

of water and seek medical advice.

S: 28 After contact with skin, wash immediately

with plenty of soap-suds.

S: 36/37 Wear suitable clothing and gloves.

S: 45 In case of accident or if you feel

unwell, seek medical advice immediately

(show the label where possible).

Section 3: Composition/Information on Ingredients

Ingredients:

Maduramicin ammonium [84878-62-5] < 1 %

Nicarbazin [330-95-0] < 10 %

Other ingredients deemed not to be hazardous to 100 %

MSDS Gromax Anticoccidial Premix - Public version

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10/30/08 13:34

Section 4: First Aid Measures

For advice, contact a Poisons Information Centre (Phone 131126)

or a doctor at once.

Swallowed: If swallowed, do NOT induce vomiting.

Skin: If skin or hair contact occurs, remove contaminated

clothing and flush skin and hair with running water.

Continue flushing with water until advised to stop by

the Poisons Information Centre or a doctor.

Eyes: If in eyes, hold eyelids apart and flush the eye

continuously with running water. Continue flushing

until advised to stop by the Poisons Information

Centre or a doctor, or for at least 15 minutes.

Inhaled: Remove from exposure, rest and keep warm. Seek medical

advice.

First Aid facilities:

Mandatory: Eye wash. Hand wash basin.

Advice to Doctor:

Product contains a low proportion of maduramicin ammonium. Harmful

in contact with skin. Contact Poisons Information Centre.

Aggravated medical conditions:

No specific data found.

Section 5: Fire Fighting Measures

HAZCHEM Code: None assigned.

Evacuate: No.

Extinguishant: Water fog or fine water spray.

Risk of violent reaction or explosion: No.

Combustible.

Possible risk of dust explosion if

finely divided in air.

Products of combustion: Oxides of carbon, oxides of

nitrogen, water vapour.

Protective Equipment: Breathing apparatus and protective

gloves for fire.

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Section 6: Accidental Release Measures

Emergency Procedures:

Contain.

Shut off all sources of ignition.

Increase ventilation.

For large spills:

Contain spillages with sand or earth. Transfer both liquid and

solids to suitable container(s). Treat residues as for small

spills.

For small spills:

Avoid generating dusts. Carefully transfer to suitable closed

container. Wash site of spillage thoroughly with water and

detergent. Ventilate area to dispel any residual dusts.

Section 7: Handling and Storage

Precautions for safe handling:

Avoid contact with skin and eyes.

Avoid breathing dusts.

Keep away from naked flames and other sources of ignition.

Conditions for safe storage:

Store in a cool, dry, well ventilated place, out of reach of

children. Store in original container. Keep container tightly

closed and out of direct sunlight. Keep away from naked flames and

other sources of ignition. Prevent dusts from collecting in

enclosed spaces. Keep away from oxidising agents. Protect from

physical damage. Clean up all spills promptly; avoid secondary

accidents.

Incompatibles:

Oxidising agents.

Section 8: Exposure Controls/Personal Protection

National Exposure Standards:

ES-TWA: None assigned by NOHSC, but see:

Maduramicin ammonium 0.1 mg/m³ [Manufacturer]

Nuisance dusts 10 mg/m³ [NOHSC]

ES-STEL: None assigned.

ES-PEAK: None assigned.

Notations: None.

Biological Limit Values: No data found.

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10/30/08 13:34

Engineering Controls:

Use flame proof equipment where available.

Ensure adequate ventilation (same as outdoors) when using.

If handling industrial quantities, or if vapour risk exists,

consider local mechanical exhaust/extraction to keep airborne

contamination as low as possible and at least below the TLV.

Personal Protective Equipment:

Avoid contact with skin and eyes. Avoid breathing dusts.

Personal protection to be selected from those recommended below,

as appropriate to mode of use, quantity handled and degree of

hazard:-

Normal Use:

Dust mask

Eye/face protection

Gloves, rubber or plastic.

Industrial Quantities:

Positive pressure air-hood

Dust mask

Face shield or safety glasses

Gloves, rubber or plastic

Plastic apron, sleeves and boots

Impervious overalls.

Section 9: Physical and Chemical Properties

Appearance: Brownish-yellow, free flowing powder.

Odour: Almost odourless.

pH: No data.

Vapour Pressure: No data.

Vapour Density: No data.

Boiling Point: No data.

Melting Point: No data.

Volatiles: < 1 %

Volatile Organic Compounds (VOC): < 1 %

Evaporation Rate: No data.

Solubilities: Insoluble in water.

Specific Gravity/Density: No data.

Flash Point: No data.

Flammable Limits: No data.

Dust Explosion: May occur.

Auto-ignition Temperature: From about 244 °C

Other Information:

May react with strong oxidising agents. May react with

concentrated mineral acids, caustic alkalis.

Section 10: Stability and Reactivity

Chemical Stability: Stable under normal conditions.

Conditions to Avoid: Incompatible materials, sources of ignition.

Incompatible Materials: Oxidising agents, strong mineral acids,

caustic alkalis.

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Hazardous Decomposition Products: Oxides of nitrogen.

Hazardous Reactions: Contact with strong oxidising agents may cause

fire.

Section 11: Toxicological Information

Health Effects:

No data available for the mixture. Information presented

relates to individual ingredients.

Acute: Swallowed: May be harmful if swallowed. Likely to cause

gastric upset, nausea, vomiting and

diarrhoea.

Skin: Harmful in contact with skin. Maduramicin

ammonium may be absorbed through the skin on

contact. Symptoms of over-exposure may

include cardiac arrhythmia (irregular heart

rate). May also be irritating to the skin.

Eyes: Irritating to eyes. Possible risk of

mechanical scratching.

Inhaled: Dusts may be irritating to the upper

respiratory system. May cause cough,

wheezing, difficulty breathing.

Over-exposure may cause cardiac arrhythmia.

Chronic: Repeated skin contact may lead to irritation and

dermatitic effects. Over-exposure of humans to maduramicin

is reported to have caused irregular heart rate, kidney

damage, damage to the peripheral nervous system,

destruction of skeletal muscle cells and death.

LD

50

: No data found.

Section 12: Ecological Information

Ecotoxicity: Toxic to aquatic organisms.

Persistence and degradability: No data.

Mobility: Readily transported by running

water.

Environmental Fate: No data.

Bioaccumulative potential: No data.

Other adverse environmental effects: No data.

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Section 13: Disposal Considerations

The generator of any wastes from this product is responsible for

its proper classification, transport and disposal.

Consult appropriate local and State regulations.

Disposal methods and containers:

Avoid disposal to sewer, natural waters or the environment.

Special precautions for landfill or incineration:

High temperature incineration.

Section 14: Transport Information

UN Number: None assigned.

UN Proper shipping name: None assigned.

Class and subsidiary risk: None assigned.

Packaging group: None assigned.

Special precautions for user: Contain spillages.

HAZCHEM Code: None assigned.

Material for export: Not regulated.

Section 15: Regulatory Information

Poisons (SUSDP): Schedule 5

Maduramicin when in animal feed premixes

containing 1 % or less of antibiotic

substances.

Dangerous Goods: No.

Carcinogen: Australia IARC NTP RTECS

No. No. No. No.

Agricultural and Veterinary Chemicals Act: Not applicable.

Australian Inventory of Chemical Substances (AICS): Listed.

Other National/International Regulations: No data.

Section 16: Other information

Date of MSDS update: April 2008

Complete review and re-write of all sections.

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Abbreviations:

NOHSC - National Occupational Health and Safety Commission.

ACGIH - American Conference of Governmental Industrial Hygienists.

MAK - Maximum workplace concentration - Germany,

maximale Arbeitsplatzkonzentration

IARC - International Agency for Research on Cancer (France).

NPT - National Toxicology Program (USA).

RTECS - Registry of Toxic Effects of Chemical Substances.

Literature references:

Other Available Sources of Data:

National Code of Practice for the Preparation of Material Safety Data

Sheets 2nd Edition [2011(2003)] - NOHSC.

Australian Dangerous Goods Code.

Standard for the Uniform Scheduling of Drugs and Poisons - AHMAC.

Exposure Standards for Atmospheric Contaminants in the

Occupational Environment [1003]- NOHSC.

List of Designated Hazardous Substances [10005] - NOHSC.

Merck Index - Merck Inc.

Sax’s Dangerous Properties of Industrial Materials - Lewis.

Handbook of Toxic and Hazardous Chemicals and Carcinogens - Sittig.

Handbook of Reactive Chemical Hazards - Bretherick.

Hawley’s Condensed Chemical Dictionary - Wiley Interscience.

AUSREG’s Chemical Data Package for PCs - AUSREG Consultancy.

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