ZENIQUIN TABLETS 100MG

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

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Active ingredient:
MARBOFLOXACIN
Available from:
ZOETIS AUSTRALIA PTY LTD
INN (International Name):
marbofloxacin(100mg/Tb)
Pharmaceutical form:
ORAL TABLET
Composition:
MARBOFLOXACIN ANTIBIOTIC Active 100.0 mg/Tb
Units in package:
50 Tablets
Class:
VM - Veterinary Medicine
Manufactured by:
ZOETIS AUSTRALIA
Therapeutic group:
CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
Therapeutic area:
ANTIBIOTIC & RELATED
Therapeutic indications:
BACILLUS SPP. | BETA-HEMOLYTIC STREPTOCOCCUS (NOT A OR B | CORYNEBACTERIUM SPP. | ENTEROCOCCUS FAECALIS | ESCHERICHIA COLI (E. COLI) | INFECTIONS OF THE SKIN | INFECTIONS OF THE URINARY TRACTS | KLEBSIELLA PNEUMONIAE | PASTEURELLA MULTOCIDA | PROTEUS MIRABILIS | PSEUDOMONAS AERUGINOSA | PSEUDOMONAS SPP. | SOFT TISSUE INFECTIONS | STAPHYLOCOCCUS AUREUS | STAPHYLOCOCCUS INTERMEDIUS | STREPTOCOCCUS SPP. | ABSCESSES | ANAL SACCULITIS | BACTERIAL CANKER | DEEP PYODERMAS | ESCHERICHIA COLI | FOWL CHOLERA | FUNGAL | GINGIVITIS | GRAM NEGATIVE BACTERIA | GRAM POSITIVE BACTERIA | GROUP D STREPTOCOCCUS | INCLUDING B-LACTAMASE PRODUCIN | INCLUDING SECONDARY INVADERS | KLEBSIELLA SPP. | NOT GROUP A | NOT GROUP B | POST-PARTURIENT INFECTIONS | PROTEUS SPP. | PSEUDOMONAS AERUGINOSA | PYODERMA | SEBORRHOEIC DERMATITIS | SEPTICAEMIA | STAPHYLOCOCCUS SPP. | YEAST
Product summary:
Poison schedule: 4; Withholding period: WHP: N/A; Host/pest details: CAT: [BACILLUS SPP., BETA-HEMOLYTIC STREPTOCOCCUS (NOT A OR B, CORYNEBACTERIUM SPP., ENTEROCOCCUS FAECALIS, ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE SKIN, PASTEURELLA MULTOCIDA, SOFT TISSUE INFECTIONS, STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS INTERMEDIUS]; DOG: [BETA-HEMOLYTIC STREPTOCOCCUS (NOT A OR B, ENTEROCOCCUS FAECALIS, ESCHERICHIA COLI (E. COLI), INFECTIONS OF THE SKIN, INFECTIONS OF THE URINARY TRACTS, KLEBSIELLA PNEUMONIAE, PASTEURELLA MULTOCIDA, PROTEUS MIRABILIS, PSEUDOMONAS AERUGINOSA, PSEUDOMONAS SPP., SOFT TISSUE INFECTIONS, STAPHYLOCOCCUS AUREUS, STAPHYLOCOCCUS INTERMEDIUS, STREPTOCOCCUS SPP.]; For the treatment in dogs of skin, soft tissue and urinary tract infections caused by organisms susceptible to marbofloxacin.
Authorization status:
Registered
Authorization number:
55005
Authorization date:
2019-07-01

Label image proudly supplied by

infopest@dpi.qld.gov.au

Product Name: Zeniquin Tablets

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:

Blend of ingredients (see below). Active ingredient is antibacterial.

Trade Name:

Zeniquin Tablets

Product Use:

Antibacterial preparation used in veterinary applications.

Creation Date:

July, 2006

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:

Xn, Harmful. Hazardous according to the criteria of SWA.

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

Risk Phrases:

R43, R62, R48/22. May cause sensitisation by skin contact. Possible risk of impaired fertility.

Harmful: danger of serious damage to health by prolonged exposure if swallowed.

Safety Phrases:

S20, S22, S28, S36, S53. When using, do not eat or drink. Do not breathe dust. After contact with

skin, wash immediately with plenty of soap and water. Wear suitable protective clothing. Avoid exposure - obtain

special instructions before use.

SUSMP Classification:

ADG Classification:

None allocated. Not a Dangerous Good under the ADG Code.

UN Number:

None allocated

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Physical Description & colour

: Beige coloured film-coated tablets.

Odour:

Mild odour.

Major Health Hazards:

possible skin sensitiser, possible risk of impaired fertility. A significant ingredient is an

antibiotic. Any person with a history of allergies to this class of substances should avoid all contact with this product

as it may cause sensitisation.

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Individuals with a history of hypersensitivity to this material or members of the quinolone class of antimicrobials and

those with known seizure disorders will be at increased risk from exposure to this product. Serious allergic reactions,

including anaphylaxia have been reported. Convulsions, increased intracranial pressure, and toxic psychosis have

been reported in patients receiving quinolones.

Skin sensitisation and/or photosensitisation (allergic response after UV exposure) of other quinolones have been

demonstrated in guinea pigs, mice and humans. There is a risk of photosensitisation within a few hours after

excessive exposure to quinolones. If excessive exposure does not occur, avoid direct sunlight and wash skin with

soap and water.

Marbofloxacin may cause cartilage deterioration in knee joints and adverse reproductive effects (based on animal

data).

Inhalation:

Short term exposure:

Long term inhalation of high amounts of any nuisance dust may overload lung clearance

mechanism. Available data indicates that this product is not harmful. However product may be mildly irritating,

although unlikely to cause anything more than mild transient discomfort.

Long Term exposure:

No data for health effects associated with long term inhalation.

Skin Contact:

Short term exposure:

Classified as a potential sensitiser by skin contact. Exposure to a skin sensitiser, once

sensitisation has occurred, may manifest itself as skin rash or inflammation, and in some individuals this reaction can

Product Name: Zeniquin Tablets

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)

be severe. However product is unlikely to cause any discomfort in normal use. Possible risk of photosensitisation

(allergic response after UV exposure).

Long Term exposure:

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

Eye Contact:

Short term exposure

: 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:

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

: The active ingredient in this product may cause effects to cartilage, liver and reproductive

system (based on animal data).

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

Marbofloxacin

115550-35-1

0.2 *

not set

Lactose

63-42-3

70-80

not set

not set

Other non hazardous ingredients

secret

to 100

not set

not set

* This is a Pfizer recommended exposure limit.

This is a commercial product whose exact ratio of components may vary slightly. Minor quantities of other non

hazardous ingredients are also possible.

The SWA 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 may be equalled (but should not be exceeded) for no

longer than 15 minutes and should not be repeated 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.

Inhalation:

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

Skin Contact:

Gently brush away excess solids. Irritation is unlikely. However, if irritation does occur, flush with

lukewarm, gently flowing water for 5 minutes or until chemical is removed.

Eye Contact:

Quickly and gently brush particles from eyes. 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. Take special care if exposed person is wearing

contact lenses.

Ingestion:

If product is swallowed or gets in mouth, do NOT induce vomiting; 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. Violent steam generation or eruption may occur upon application of direct water stream on hot

liquids.

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

Extinguishing Media

: Preferred extinguishing media are carbon dioxide, dry chemical, foam, water fog.

Fire Fighting

: If a significant quantity of this product is involved in a fire, call the fire brigade.

Flash point

:

Combustible but does not meet the AS 1940 definition of a Flammable Liquid.

Upper Flammability Limit:

No data.

Lower Flammability Limit:

No data.

Autoignition temperature:

No data.

Product Name: Zeniquin Tablets

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)

Flammability Class:

No data.

Section 6 - Accidental Release Measures

Accidental release

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

protective clothing including eye/face protection. All skin areas should be covered. See below under Personal

Protection regarding Australian Standards relating to personal protective equipment. Suitable materials for protective

clothing include cotton, rubber, PVC. Eye/face protective equipment should comprise as a minimum, protective

glasses and, preferably, goggles. 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. Use a P1 mask, designed for use against mechanically generated

particles eg silica & asbestos.

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. Refer to product label for specific instructions. After spills, wash area

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

Full details regarding disposal of used containers, spillage and unused material may be found on the label. If there is

any conflict between this MSDS and the label, instructions on the label prevail. 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 schedule of poison. Protect this product from light. 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.

Exposure limits *

TWA (mg/m

3

)

STEL (mg/m

3

)

Marbofloxacin

not set

* Note: this is a Pfizer recommended limit.

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:

This product should only be used where there is ventilation that is adequate to keep exposure below

the TWA levels. If necessary, use a fan.

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:

If you believe you may have a sensitisation to this product or any of its declared ingredients, you

should prevent skin contact by wearing impervious gloves, clothes and, preferably, apron. Make sure that all skin

areas are covered. See below for suitable material types.

Protective Material Types:

We suggest that protective clothing be made from the following materials: cotton,

rubber, PVC.

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.

Safety deluge showers should, if practical, be provided near to where this product is being used.

Section 9 - Physical and Chemical Properties:

Physical Description & colour

Beige coloured film-coated tablets.

Odour:

Mild odour.

Boiling Point:

No specific data. Expected to decompose before boiling.

Freezing/Melting Point:

No specific data. Solid at normal temperatures.

Volatiles:

No specific data. Expected to be low at 100°C.

Vapour Pressure:

Negligible at normal ambient temperatures.

Product Name: Zeniquin Tablets

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)

Vapour Density:

No data.

Specific Gravity:

No data.

Water Solubility:

Mostly soluble.

pH:

No data.

Volatility:

Negligible at normal ambient temperatures.

Odour Threshold:

No data.

Evaporation Rate:

No data.

Coeff Oil/water distribution

No data

Autoignition temp:

No data.

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:

Protect this product from light. Store in the closed original container in a dry, cool, well-

ventilated area out of direct sunlight.

Incompatibilities:

water, acids, bases, strong oxidising agents.

Fire Decomposition:

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

skin

Weakly positive effects in the Ames test strain TA 102 and gene mutation assays with yeast are typical of quinoline

antimicrobials due to their mode of action.

Oral studies of up to 3 months’ duration have been conducted in dogs and rats. At the highest dose of 600mg/kg in

rats, findings included obstructive changes in the urinary tract with increased mortality, testicular atrophy and

decreased weights of the testes and male accessory glands. Doses of 50mg/kg or higher in rats caused changes in

joint cartilage. In dogs, joint cartilage lesions were found at doses of 10mg/kg/day and higher. All findings were

considered to be typical for the fluoroquinolone class of antibacterials.

Long term toxicity studies to evaluate the carcinogenic potential of marbofloxacin were conducted in rats at dose

levels up to 250mg/kg/day and in mice at dose levels up to 600mg/kg/day. Proliferation of bile ducts in the liver and

effects on cartilaginous tissues were observed in rats at doses greater than 20mg/kg/day.

In a 2-generation reproduction safety study in rats, the highest dose of 500mg/kg/day cause testicular effects with

reduced fertility in males. Among pregnant females, effects at 500mg/kg/day included reduced implantation rates,

increased post-implantation losses, reduced litter size, increased pup mortality and reduced pup weight gains. These

effects occur with other quinolone antimicrobials as well.

No teratogenic effects were observed in oral studies in rats and rabbits.

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Ingredient

Risk Phrases

No ingredient mentioned in the HSIS Database is present in this product at hazardous concentrations.

For Marbofloxacin:

Oral (Rat) = 2720-3772mg/kg

Oral (Mouse) = 1781-1822mg/kg

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:

There are many pieces of legislation covering waste disposal and they differ in each state and territory, so

each user must refer to laws operating in their area. In some areas, certain wastes must be tracked. The Hierarchy of

Controls seems to be common - the user should investigate: Reduce, Reuse, and Recycle and only if all else fails

should disposal be considered. Note that properties of a product may change in use, so that the following suggestions

may not always be appropriate. The following may help you in properly addressing this matter for this product. Special

help is available for the disposal of Agricultural Chemicals. The product label will give general advice regarding

disposal of small quantities, and how to cleanse containers. However, for help with the collection of unwanted rural

chemicals, contact ChemClear 1800 008 182 http://www.chemclear.com.au/ and for help with the disposal of empty

drums, contact DrumMuster http://www.drummuster.com.au/ where you will find contact details for your area.

Product Name: Zeniquin Tablets

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)

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 compliant with NICNAS regulations.

The following ingredients: Marbofloxacin, 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

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

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

MSDS43-VERSION1

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