RUMIFERT MINERAL BOLUS FOR CATTLE

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

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Active ingredient:
COBALT; COPPER; SELENIUM
Available from:
BIMEDA (AUSTRALIA) PTY LIMITED
INN (International Name):
copper (Cu)(13.4g/Bs)+cobalt(0.5g/Bs)+selenium(0.3g/Bs)
Pharmaceutical form:
ORAL CAPSULE
Composition:
COBALT MINERAL-COBALT Active 500.0 mg/PB; COPPER MINERAL-COPPER Active 13400.0 mg/PB; SELENIUM MINERAL-SELENIUM Active 300.0 mg/PB
Units in package:
(5 foil; 20 Boluses; 4 boluses); pouches x
Class:
VM - Veterinary Medicine
Manufactured by:
BIMEDA (AUSTRALIA)
Therapeutic group:
CATTLE | BEEF | BOS INDICUS | BOS TAURUS | BOVINE | BUFFALO | BULL | BULLOCK | CALF | COW | DAIRY COW | HEIFER | STEER
Therapeutic area:
NUTRITION & METABOLISM
Therapeutic indications:
COPPER DEFICIENCY | IRON & HAEMOPOIETIC AGENT | MINERAL AND NUTRITIONAL ADDITIVE | SELENIUM DEFICIENCY | ACETONAEMIA | ACTINOBACILLOSIS | AMINO ACID SUPPLEMENT | AMINO ACIDS | ANAEMIA | BONE FRAGILITY | BONE GROWTH | CALCIUM SUPPLEMENT | CARTILAGE STRENGTH | COPPER DEFICIENCY | EGG SHELL | FATTY ACID DEFICIENCY | FATTY LIVER | GLUCOSE | GRASS TETANY | HAEMOPOIETIC AGENTS | HEMATINIC | HEPATOTOXIC DRUGS | HYPOCALCAEMIA | HYPOMAGNESAEMIA | ILEITIS | IODINE DEFICIENCIES | IRON DEFICIENCY | LACTATING | LAXATIVE | L-CARNITINE SUPPLEMENT | LIVER ABSCESS | LIVER DAMAGE | LYSINE DEFICIENCIES | MILK FEVER | MINERAL ADDITIVE | MYOPATHIES | MYOSITIS SYNDROME | PANGAMIC ACID | PHOSPHOROUS SUPPLEMENT | RICKETS | SELENIUM DEFICIENCY | SHELL STRENGTH | SOFT BONE DISEASE | VITAMIN B12 | VITAMIN D SUPPLEMENT | VITAMIN E DEFICIENCIES | WHITE MUSCLE DISEASE | ZINC DEFICIENCIES
Product summary:
Poison schedule: 5; Withholding period: WHP: Nil; Host/pest details: CATTLE: [COPPER DEFICIENCY, IRON & HAEMOPOIETIC AGENT, MINERAL AND NUTRITIONAL ADDITIVE, SELENIUM DEFICIENCY]; Copper, cobalt and selenium nutritional supplement in a slow release glass bolus for ruminating cattle effective for up to 6 months.See Contraindications on label.
Authorization status:
Registered
Authorization number:
48197
Authorization date:
2020-07-01

RUMIFERT MINERAL BOLUS FOR CATTLE

48197 / 108077

Product Name:

APVMA Approval No:

Label Name:

RUMIFERT MINERAL BOLUS FOR CATTLE

Signal Headings:

CAUTION

KEEP OUT OF REACH OF CHILDREN

FOR ANIMAL TREATMENT ONLY

READ SAFETY DIRECTIONS BEFORE OPENING OR USING

Constituent

Statements:

Each bolus contains:

13.4g COPPER

0.5 g COBALT

0.3 g SELENIUM

Claims:

Copper, Cobalt and Selenium nutritional supplement in a slow release glass bolus for

ruminating cattle effective for up to 6 months

Net Contents:

20 Boluses(5 foil pouches x 4 boluses)

2 kg NET

Directions for Use:

Restraints:

Contraindications:

This product is contraindicated for use when selenium intake from pasture is high or

selenium is provided by other means (such as top dressing, vaccine, pellets or selenium

drenches), if blood selenium levels at treatment are high. Users can determine selenium

status by consulting their veterinarian.

Excessive copper is toxic. This product is contraindicated for use unless copper deficiency

is confirmed.

This product is contraindicated for use unless cobalt deficiency is confirmed

Do not administer additional copper orally or by injection, or selenium by injection, while the

boluses are still active (6 months), unless advised by a veterinarian.

Do not use any damaged or discoloured bolus.

RLP

APPROVED

This product is contraindicated for use in animals that are dehydrated or unwell.

This product is contraindicated for use in non-ruminating calves.

This product is contraindicated for use in cattle less than 5 months of age.

This product is contraindicated for use in cattle less than 150 kg body weight.

Precautions:

Minerals such as copper, cobalt, selenium, iron, manganese and molybdenum compete

with each other for metabolically important processes in the animal. Users should seek

veterinary advice before treatment.

The use of aids to dissolution of the bolus such as steel grinders or grub screws is

contraindicated. Rapid disintegration of the RUMIFERT ™ MINERAL BOLUS FOR

CATTLE may occur if used in conjunction with other ruminal devices. This rapid

disintegration could lead to selenium toxicity.

Side Effects:

Dosage and

Administration:

For oral administration only.

Administer using the RUMIFERT ™ MINERAL BOLUS FOR CATTLE applicator and follow

full instructions supplied with the

applicator.

Ruminating calves (over 5 months and 150 kg bodyweight) and growing and adult cattle : 2

boluses

Boluses may crack if warmed too quickly.

Boluses must be at room temperature prior to administration.

Give orally by the RUMIFERT ™ MINERAL BOLUS FOR CATTLE applicator which delivers

the bolus directly into the top of the gullet. Great care should be taken not to cause any

injury by rough handling or by placing the gun too far inside the throat of the animal. Ensure

that each animal has swallowed the bolus by holding the mouth closed and observing

the animal for a short time after dosing. To minimise the risk of regurgitation, avoid rough

handling of the animals after dosing.

General Directions:

Use RUMIFERT ™ MINERAL BOLUS FOR CATTLE where deficiencies of the elements

are known to occur. In cases where the trace element status of a herd is uncertain or where

profound trace element deficiencies exist, veterinary advice should

be sought before dosing animals with RUMIFERT ™ MINERAL BOLUS FOR CATTLE.

Withholding Periods:

Trade Advice:

Safety Directions:

May irritate skin. Avoid contact with skin and wash hands after use.

Persons sensitive to cobalt should wear gloves when handling the boluses.

First Aid Instructions:

If poisoning occurs, contact a doctor or Poisons Information Centre.

Phone :Australia 131 126.

First Aid Warnings:

Additional User

Safety:

Environmental

Statements:

Disposal:

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

regurgitated boluses should be disposed of in a disposal pit specially marked and set up for

this purpose clear of waterways, vegetation and roots.

Storage:

Store below 30° C (room temperature) in the original container in a dry place.

SAFETY DATA SHEET

RUMIFERT MINERAL BOLUS FOR CATTLE

Infosafe No.: LQ5RZ

Draft Date: 12/08/2016

Draft by: Boehringer Ingelheim Pty Limited

1. IDENTIFICATION

GHS Product Identifier

RUMIFERT MINERAL BOLUS FOR CATTLE

Company Name

Boehringer Ingelheim Pty Limited

Address

78 Waterloo Rd North Ryde

NSW 2113 Australia

Telephone/Fax Number

Tel: 1800 038 037

Fax: +61 2 8875 8715

Emergency phone number

1800 038 037

E-mail Address

animalhealth.au@boehringer-ingelheim.com

Recommended use of the chemical and restrictions on use

Soluble glass mineral

boluses that provides supplementation of copper,

cobalt and selenium in ruminating cattle for up to six

months from one administration.

2. HAZARD IDENTIFICATION

GHS classification of the substance/mixture

classified as Hazardous according to the Globally Harmonised System of

Classification and Labelling of

Chemicals (GHS)

including Work, Health and Safety regulations, Australia.

Not classified as Dangerous Goods according to the Australian Code for the Transport of Dangerous Goods by Road and Rail. (7th

edition)

3. COMPOSITION/INFORMATION ON INGREDIENTS

Ingredients

Name

Proportion

Phosphate glass

Not available

100 %

Copper

7440-50-8

13.4% (as a component of

phosphate glass)

Cobalt

7440-48-4

0.5% (as a component of

phosphate glass)

Selenium

7782-49-2

0.3% (as sodium selenate in

phosphate glass)

Page 1 / 7

4. FIRST-AID MEASURES

Inhalation

If inhaled, remove affected person from contaminated area. Keep at rest until recovered. If symptoms develop and/or persist seek

medical attention.

Ingestion

Do not induce vomiting. Wash out mouth thoroughly with water. Seek medical attention.

Skin

Wash affected area thoroughly with soap and water. If symptoms develop seek medical attention.

Eye contact

If in eyes,

hold eyelids apart and flush the eyes continuously with running water.

Remove contact lenses.

Continue flushing for

several minutes until all contaminants are washed out completely. If symptoms develop and/or persist seek medical attention.

First Aid Facilities

Eyewash and normal washroom facilities.

Advice to Doctor

Treat symptomatically.

5. FIRE-FIGHTING MEASURES

Suitable Extinguishing Media

Use appropriate fire extinguisher for surrounding environment.

Hazards from Combustion Products

Non-combustible material.

Specific Hazards Arising From The Chemical

This product is non-combustible.

Decomposition Temperature

Not available

Precautions in connection with Fire

Fire fighters should wear full

protective clothing and self-contained breathing apparatus (SCBA)

operated in positive pressure

mode. Fight fire from safe location.

6. ACCIDENTAL RELEASE MEASURES

Emergency Procedures

Increase ventilation.

Evacuate all

unprotected personnel.

Wear sufficient respiratory protection and full

protective clothing to

prevent exposure. Sweep up material avoiding dust generation or dampen spilled material with water to avoid airborne dust, then

transfer material

to a suitable container.

Wash surfaces well

with soap and water.

Seal

wastes in labelled containers for

subsequent recycling or disposal.

Dispose of waste according to the applicable local and national regulations.

If contamination of

sewers or waterways occurs inform the local water and waste management authorities in accordance with local regulations.

7. HANDLING AND STORAGE

Precautions for Safe Handling

Avoid inhalation of dust,

and skin or eye contact.

Use only in a well

ventilated area.

Keep containers sealed when not in use.

Prevent the build up of dust in the work atmosphere.

Maintain high standards of personal

hygiene i.e.

Washing hands prior to

eating, drinking, smoking or using toilet facilities.

Conditions for safe storage, including any incompatibilities

Store in a cool, dry, well-ventilated area, out of direct sunlight and moisture. Store in suitable, labelled containers. Keep containers

tightly closed.

Store away from incompatible materials.

Ensure that storage conditions comply with applicable local

and national

regulations.

8. EXPOSURE CONTROLS/PERSONAL PROTECTION

Page 2 / 7

Occupational exposure limit values

No exposure standards have been established for this material.

However,

the available exposure limits for ingredients are listed

below:

Cobalt

TWA 0.05 as dust & fume (Co)

Copper

TWA: 1 mg/m³ (dusts and mists as Cu); 0.2 mg/m³ (fume)

Dusts (not otherwise specified):

TWA: 10 mg/m³

Selenium compounds (as Se)

TWA: 0.1 mg/m³

TWA (Time Weighted Average): The average airborne concentration of a particular substance when calculated over a normal eight-

hour working day, for a five-day week.

Biological Limit Values

Name: Cobalt

Determinant: Cobalt in urine

Value: 15 ug/L

Sampling time: End of shift at end of workweek

Determinant: Cobalt in blood

Value: 1 ug/L

Sampling time: End of shift at end of workweek

Source: American Conference of Industrial Hygienists (ACGIH)

Appropriate Engineering Controls

Use with good general ventilation. If dusts are produced, local exhaust ventilation should be used.

Respiratory Protection

If engineering controls are not effective in controlling airborne exposure then an approved respirator with a replaceable dust/

particulate filter

should be used.

Refer

to relevant

regulations

further

information concerning respiratory protective

requirements.

Reference should be made to Australian/New Zealand Standards AS/NZS 1715,

Selection,

Use and Maintenance of Respiratory

Protective Devices;

and AS/NZS 1716,

Respiratory Protective Devices,

in order to make any necessary changes for individual

circumstances.

Eye Protection

Safety glasses with side shields, chemical goggles or full-face shield as appropriate should be used. Final choice of appropriate eye/

face protection will vary according to individual circumstances. Eye protection devices should conform to relevant regulations. Eye

protection should conform with Australian/New Zealand Standard AS/NZS 1337 - Eye Protectors for Industrial Applications.

Hand Protection

Wear gloves of impervious material. Final choice of appropriate gloves will vary according to individual circumstances. i.e. methods

of handling or according to risk assessments undertaken. Occupational protective gloves should conform to relevant regulations.

Reference should be made to AS/NZS 2161.1: Occupational protective gloves - Selection, use and maintenance.

Body Protection

Suitable protective work wear,

e. g.

cotton overalls buttoned at neck and wrist is recommended.

Chemical

resistant apron is

recommended where large quantities are handled.

Page 3 / 7

9. PHYSICAL AND CHEMICAL PROPERTIES

Properties

Description

Properties

Description

Form

Solid

Appearance

Solid sintered glass. Moisture

attack on surface leads to

white copper phosphate

deposits.

Colour

Blue

Odour

Odourless

Decomposition Temperature

Not available

Melting Point

Not available

Boiling Point

Not available

Solubility in Water

Slowly in cold water. Rapid in

boiling water and

approximately 0.22 g/hr at

40°C. Soluble in acidic and

basic solutions.

Specific Gravity

Not available

6.7 (10 g/l aqueous solution)

(20°C) (approximate)

Vapour Pressure

Not applicable

Vapour Density (Air=1)

Not applicable

Evaporation Rate

Not applicable

Odour Threshold

Not available

Viscosity

Not applicable

Volatile Component

Not available

Partition Coefficient: n-

octanol/water

Not available

Density

2.75 g/cm³

Flash Point

Not applicable

Flammability

Non-combustible

Auto-Ignition Temperature

Not applicable

Explosion Limit - Upper

Not applicable

Explosion Limit - Lower

Not applicable

Other Information

Weight: 100 g (+/- 5 g)

10. STABILITY AND REACTIVITY

Reactivity

Not available

Chemical Stability

Stable under normal conditions of storing and handling.

Reactivity and Stability

Not available

Conditions to Avoid

Extremes of temperature and direct sunlight. Dusty conditions.

Incompatible materials

Not available

Hazardous Decomposition Products

Thermal decomposition may result in the release of toxic and/or irritating fumes.

Possibility of hazardous reactions

Not available

Hazardous Polymerization

Not available

Page 4 / 7

11. TOXICOLOGICAL INFORMATION

Toxicology Information

No toxicity data available for this product.

Ingestion

Ingestion of this product may irritate the gastric tract causing nausea and vomiting.

Inhalation

Inhalation of

dusts may irritate the respiratory system.

Chronic exposure to this material

may aggravate existing respiratory

disorders

and lung disorders

such as

bronchitis,

emphysaema and asthma.

Onset

and progression are related to dust

concentrations and duration of exposure.

Skin

Skin contact may cause mechanical irritation resulting in redness and itching.

Eye contact may cause mechanical irritation. May result in mild abrasion.

Respiratory sensitisation

Not expected to be a respiratory sensitiser.

Skin Sensitisation

Not expected to be a skin sensitiser.

Germ cell mutagenicity

Not considered to be a mutagenic hazard.

Carcinogenicity

Not considered to be a carcinogenic hazard.

Cobalt (and cobalt compounds)

is listed as a Group 2B:

Possibly carcinogenic to humans according to International

Agency for

Research on Cancer (IARC).

Reproductive Toxicity

Not considered to be toxic to reproduction.

STOT-single exposure

Not expected to cause toxicity to a specific target organ.

STOT-repeated exposure

Not expected to cause toxicity to a specific target organ.

Aspiration Hazard

Not expected to be an aspiration hazard.

12. ECOLOGICAL INFORMATION

Ecotoxicity

No ecological data available for this material.

Persistence and degradability

Not available

Mobility

Not available

Bioaccumulative Potential

Not available

Other Adverse Effects

Not available

Environmental Protection

Prevent this material entering waterways, drains and sewers.

Page 5 / 7

13. DISPOSAL CONSIDERATIONS

Disposal considerations

The disposal of the spilled or waste material must be done in accordance with applicable local and national regulations.

14. TRANSPORT INFORMATION

Transport Information

Road and Rail Transport (ADG Code):

Not classified as Dangerous Goods according to the Australian Code for the Transport of Dangerous Goods by Road and Rail. (7th

edition).

Marine Transport (IMO/IMDG):

classified as

Dangerous

Goods

by the criteria of

the International

Transport

Association (IATA)

Dangerous

Goods

Regulations for transport by air.

Air Transport (ICAO/IATA):

Not classified as Dangerous Goods by the criteria of the International Maritime Dangerous Goods Code (IMDG Code) for transport

by sea.

U.N. Number

None Allocated

UN proper shipping name

None Allocated

Transport hazard class(es)

None Allocated

Special Precautions for User

Not available

IMDG Marine pollutant

Transport in Bulk

Not available

15. REGULATORY INFORMATION

Regulatory information

classified as Hazardous according to the Globally Harmonised System of

Classification and labelling of

Chemicals (GHS)

including Work, Health and Safety regulations, Australia.

Not classified as a Scheduled Poison according to the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP).

Poisons Schedule

Not Scheduled

16. OTHER INFORMATION

Date of preparation or last revision of SDS

SDS Created: August 2016

References

Preparation of Safety Data Sheets for Hazardous Chemicals Code of Practice

Standard for the Uniform Scheduling of Medicines and Poisons.

Australian Code for the Transport of Dangerous Goods by Road & Rail.

Model Work Health and Safety Regulations, Schedule 10: Prohibited carcinogens, restricted carcinogens and restricted hazardous

chemicals.

Workplace exposure standards for airborne contaminants, Safe work Australia.

American Conference of Industrial Hygienists (ACGIH)

Page 6 / 7

Globally Harmonised System of classification and labelling of chemicals.

END OF SDS

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