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Material Safety Data Sheet
Flusapex Tablets Diuretic
Not classified as hazardous according to the criteria of NOHSC

SECTION I Identification of the Material and Supplier
Product Name Flusapex Tablets Diuretic
Recommended Use Diuretic used to treat oedema such as that associated with congestive heart failure, surgery and trauma.
Supplier Details Apex Laboratories Pty. Ltd.
ACN Number 000 397 240
Street 61 Chivers Road
Suburb Somersby
State NSW
Country Australia
Post Code 2250
Phone +61 2 4372 1661 (Business hours – 8.30am – 5.00pm)
Fax +61 2 4372 1668 (fax)
Website http://www.apexlabs.com.au
Emergency contact As above or Poisons Information Centre 131126 (Australia)

SECTION II Hazard Identification
Classification Not classified as hazardous according to the criteria of NOHSC
Risk Phrases None allocated
Safety Phrases None allocated
ADG Class None allocated
Hazchem Code None allocated
Poisons Schedule S4

SECTION III Composition
Ingredients CAS No Proportion TWA mg/m3 STEL mg/m3
Frusemide 54-31-9 10-<30% not set not set
Other non hazardous ingredients NA to 100% NA NA
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 over an entire working lifetime. The TWA exposure standard set by Worksafe Australia for dusts not otherwise specified is 10mg/m3. 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.

SECTION IV First Aid Measures
This first aid information pertains particularly to the active ingredients and any hazardous ingredients, rather than to the formulated product. As the finished product is a tablet for oral or intrauterine administration to animals, inhalation and ingestion by humans are unlikely to occur or to pose a problem.
Ingestion If swallowed rinse mouth out with water, give water to drink, DO NOT induce vomiting and seek medical advice.
Eye Irrigate with copious quantities of lukewarm water for 10 minutes and seek medical advice.
Skin Wash well with soap and water and if concerned seek medical advice.
Inhalation Generally not required. If concerned move to fresh air and seek medical advice.

SECTION V Fire Fighting Measures
Extinguishing Media Dry agent, water fog, mist or spray, carbon dioxide. As appropriate for surrounding material.
Combustion Hazards Some of the ingredients in this formulation can emit oxides of nitrogen, sulfur and carbon under fire conditions.
Precautions for Firefighters Wear self contained breathing apparatus and protective clothing.
Hazchem Code None allocated.

SECTION VI Accidental Release Measures
Emergency Procedures Spillage of formulated product from marketed packaging is unlikely to ever be serious, however, in the event of a major spill, protect drains and water courses from contamination.
Materials and Methods Wear protective clothing (overalls, goggles, gloves and boots) and prevent further spillage. Shovel spillage into labelled containers and dispose after consulting appropriate authorities.

SECTION VII Handling and Storage
Precautions Always use good occupational work practices and observe recommendations on the label. Keep exposure to this product to a minimum. Prohibit eating, drinking and smoking in storage and handling areas. Wash hands after handling and remove contaminated clothing and any protective equipment before entering eating areas.
Conditions Store product in original containers as per label instruction (below 25oC, air conditioning).

SECTION VIII Exposure Controls and Personal Protection
National Exposure Standards No exposure standard has been allocated for this mixture or any significant ingredient within this mixture.
Biological Limit Values No biological limit has been allocated for this mixture.
Engineering Controls No specific engineering controls are required for this mixture.
Personal Protective Equipment
Eye Eye protection is not normally necessary. If concerned wear protective goggles or glasses. Wash hands after handling and prior to touching eye and in particular handling contact lenses.
Skin Skin protection is not normally necessary, however it is good practice to avoid contact with chemicals by wearing suitable gloves when handling.
Respiratory Protection from inhalation is not normally necessary. If ventilation is inadequate or dust is likely to build up then use of a suitable dust mask would be appropriate.

SECTION IX Physical and Chemical Properties
Appearance White tablets.
Odour Non specific odour.
pH No data available.
Vapour pressure No data available.
Boiling point/range No data available.
Freezing/Melting point No data available.
Solubility No data available.
Specific gravity/density No data available.
Flash Points No data available.
Flammable limits (in air) No data available.
Ignition temperature No data available.

SECTION X Stability and Reactivity
Chemical stability This mixture is stable under normal ambient and anticipated storage and handling conditions of temperature and pressure.
Conditions to avoid No specific conditions to avoid other than extreme heat.
Incompatible materials No data available.
Decomposition products No known decomposition products.
Hazardous reactions No data available.

SECTION XI Toxicological Information
Handling of the formulated product is not expected to cause any adverse affects. The following data pertains particularly to the active and any hazardous ingredients in the formulation, rather than this specific formulation.
Acute Health Effects  
Ingestion The data available suggests that ingestion of large quantities may result in moderate irritation of the gastrointestinal tract. Frusemide is a diuretic and so large doses may lead to fluid and electrolyte imbalance. Infrequent side effects of frusemide therapy include allergy nausea, diarrhoea, blurred vision, dizziness, headache, pancreatitis, photosensitivity, skin rashes, muscle spasm, hypotension, agranulocytosis, aplastic anaemia, thrombocytopaenia and leucopaenia, liver damage, paraesthesia, tinnitus and transient deafness.
Eye Eye contact is not a great risk as this product is a tablet. The data available suggests that eye contact may result in a transient irritation and associated redness and temporary vision impairment or eye damage/ulceration.
Skin Skin contact is not a great risk as this product is a tablet. The data available suggests that skin contact may result in mild discomfort, especially to open wounds or abrasions.
Inhalation Inhalation is not a great risk as this product is a tablet. The data available suggests that inhalation may cause mild irritation to the respiratory tract, especially in patients with pre-existing pulmonary disease.
Chronic Health Effects  
Ingestion There is no data available regarding the chronic health effects of this formulation.
Eye There is no data available regarding the chronic health effects of this formulation.
Skin There is no data available regarding the chronic health effects of this formulation.
Inhalation There is no data available regarding the chronic health effects of this formulation.
Advice to Doctor Treatment for any adverse effects should be symptomatic. If overdoses are significant, treatment should be directed at correction and maintenance of fluid and electrolyte derangement. If ingestion is recent then gastric lavage should be considered.
Carcinogenicity No ingredient in this formulation is known to be carcinogenic.
Compounding effects Frusemide crosses the placenta and is excreted in milk.

SECTION XII Ecological Information
Ecotoxicity No data available.
Persistence and Degradability No data available.
Mobility No data available.

SECTION XIII Disposal Considerations
Disposal Methods Empty containers may be recycled or sent to a commercial waste disposal site. Unused product should be suitable for landfill however contact the relevant local Waste Disposal Authority.
Special Precautions Do not dispose into sewers or waterways.

SECTION XIV Transport Information
UN Number None allocated.
UN Shipping Name None allocated.
ADG Class None allocated
Packing Group None allocated.
Special Precautions None allocated.
Hazchem Code None allocated

SECTION XV Regulatory Information
Poisons Schedule S4

SECTION XVI Other Information
Date This MSDS has been reviewed and updated as required in May 2009.
   
Key to Abbreviations  
NOHSC: National Occupational Health and Safety Commission
ADG Class: Australian Dangerous Goods Class
CAS Number: Chemical Abstracts Service Number
TWA: Time Weighted Average
STEL: Short Term Exposure Limit
UN: United Nations
 
Disclaimer
This Material Safety Data Sheet has been developed according to WORKSAFE Australia, NOHSC Guidelines. Hazard Classifications have been determined in consultation with the Approved Criteria for Classifying Hazardous Substances [NOHSC:1008(1999)]. However, to the best of our knowledge, the finished product is unlikely to cause harm to humans handling, administering and dispensing as per label instructions. The data, information and recommendations herein are represented in good faith and are believed to be correct as of the date hereof. The purpose of this Material Safety Data Sheet is to describe products in terms of their safety requirements. Apex Laboratories Pty Ltd make no representation of merchantability, fitness for a particular purpose or application, or of any other nature with respect to the information or the product to which the information refers ("the product"). The information is supplied upon the condition that the persons receiving same will make their own determination as to its suitability prior to use of the product. The physical data shown herein are typical values based on material tested. These values should not be construed as guaranteed analysis of any specific lot or as guaranteed specification for the product or specific lots hereof. Due care should be taken to make sure that the use or disposal of this product and/or its packaging is in compliance with relevant Federal, State and Local Government Regulations.