PRED-X

Main information

  • Trade name:
  • PRED-X 5 ANTI-INFLAMMATORY - ANTI-ALLERGY
  • Pharmaceutical form:
  • ORAL TABLET
  • Units in package:
  • 1000Tab
  • Class:
  • Veterinary Medicine
  • Medicine domain:
  • Animals
  • Medicine type:
  • Allopathic drug
  • Manufactured by:
  • APEX LABORATORIES

Documents

Localization

  • Available in:
  • PRED-X 5 ANTI-INFLAMMATORY - ANTI-ALLERGY
    Australia
  • Language:
  • English

Therapeutic information

  • Therapeutic group:
  • CAT | DOG | BITCH | CASTRATE | CAT - QUEEN | CAT - TOM | KITTEN | PUPPY
  • Therapeutic area:
  • corticosteroid
  • Therapeutic indications:
  • ARTHRITIS | DERMATOSES | RHEUMATIC JOINT DISEASE
  • Product summary:
  • For the treatment of dermatoses and as an aid in the treatment of arthritic and rheumatic joint disease in dogs and cats.

Other information

Status

  • Source:
  • Australian Pesticides and Veterinary Medicines Authority (APVMA)
  • Authorization status:
  • Registered and available
  • Authorization number:
  • 35702/100559
  • Authorization date:
  • 05-11-2015
  • Last update:
  • 15-06-2017

Summary of Product characteristics: dosage,interactions,side effects

Material Safety Data Sheet

Pred-X Anti-Inflammatory Anti-Allergy 5mg & 20mg Tablets

Classified as hazardous according to the criteria of NOHSC

Product Name Pred-X Anti-Inflammatory Anti-Allergy 5mg & 20mg Tablets

Recommended Use To treat allergic dermatoses and inflammatory arthritic conditions in

horses, dogs and cats.

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)

+61 2 4372 1668 (fax)

Website http://www.apexlabs.com.au

Emergency contact As above or Poisons Information Centre 131126 (Australia)

Classification Classified as hazardous according to the criteria of NOHSC

Risk Phrases R40 Possible risks of irreversible effects. R61 May impair fertility

Safety Phrases None allocated

ADG Class None allocated

Hazchem Code None allocated

Poisons Schedule S4

Ingredients CAS No Proportion TWA mg/m3 STEL mg/m3

Prednisolone 50-24-8 <10% 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.

Ingestion Rinse mouth with water, give water to drink and seek medical advice.

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.

Extinguishing Media Dry chemical powder, water fog, mist or spray, carbon dioxide. As

appropriate for surrounding material.

Combustion Hazards Oxides of carbon may be emitted in fire situations.

MSDS|Pred-X Anti-Inflammatory Anti-Allergy 5mg & 20mg Tablets

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/43/Pred-X+Anti-Inflammatory+Anti-Allergy++5mg+%26+20mg+Tablets/pdf

SECTION I Identification of the Material and Supplier

SECTION II Hazard Identification

SECTION III Composition

SECTION IV First Aid Measures

SECTION V Fire Fighting Measures

Precautions for Firefighters Wear self contained breathing apparatus and protective clothing.

Hazchem Code None allocated

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, gloves, goggles and boots). Shovel

spillage into clean, dry, labelled containers and dispose after consulting

appropriate authorities. Take care not to slip.

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 30oC or

room temperature).

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 protection is not normally necessary. If there is risk of significant dust

formation 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.

Appearance White round tablets.

Odour Non specific odour.

No data available.

Vapour pressure No data available.

Boiling point/range No data available.

Freezing/Melting point No data available.

Solubility Practicably insoluble.

Specific gravity/density No data available.

Flash Points No data available.

Flammable limits (in air) No data available.

Ignition temperature No data available.

MSDS|Pred-X Anti-Inflammatory Anti-Allergy 5mg & 20mg Tablets

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/43/Pred-X+Anti-Inflammatory+Anti-Allergy++5mg+%26+20mg+Tablets/pdf

SECTION VI Accidental Release Measures

SECTION VII Handling and Storage

SECTION VIII Exposure Controls and Personal Protection

SECTION IX Physical and Chemical Properties

SECTION IX Physical and Chemical Properties

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.

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

Eye contact is not a great risk as this product is a tablet. The data

available suggests that eye contact may result in a irritation and

associated blinking, lacrimation and pain.

Skin Skin contact is not a great risk as this product is a tablet. The data

available suggests that skin contact may result in irritation.

Inhalation Inhalation is not a great risk as this product is a tablet. The data available

suggests that inhalation may produce irritation.

Chronic Health Effects

Ingestion Chronic exposure to corticosteroids may lead to pituitary-adrenal

suppression and Cushings Disease (Hyperadrenocortism). Symptoms

may include redistribution of body fat, immunosuppression, osteoporosis,

cataracts, glaucoma, mental disturbances, hyperglycaemia and

glycosuria, muscular weakness and fatigue, acne, menstrual disorders

and peptic ulcers. Electrolyte imbalances may also be seen, in particular

loss of potassium.

There is no data available on the effects of chronic exposure to this

formulation.

Skin There is no data available on the effects of chronic exposure to this

product.

Inhalation There is no data available on the effects of chronic exposure to this

formulation.

Advice to Doctor Treatment for any adverse effects should be symptomatic. This product

contains a glucocorticoid.

Carcinogenicity No ingredient in this formulation is known to be carcinogenic.

Compounding effects Corticosteroids are considered to be teratogenic in laboratory animals.

Although there are no well controlled studies performed in women, high

dose administration in some pregnant women had no apparent effect on

the developing foetus.

Ecotoxicity No data available.

Persistence and Degradability No data available.

Mobility No data available.

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.

MSDS|Pred-X Anti-Inflammatory Anti-Allergy 5mg & 20mg Tablets

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/43/Pred-X+Anti-Inflammatory+Anti-Allergy++5mg+%26+20mg+Tablets/pdf

SECTION XI Toxicological Information

SECTION XII Ecological Information

SECTION XIIIDisposal Considerations

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

Poisons Schedule S4

Date This MSDS has been reviewed and updated as required in May 2009.

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.

MSDS|Pred-X Anti-Inflammatory Anti-Allergy 5mg & 20mg Tablets

Apex Laboratories Pty. Ltd. | ACN 000 397 240 | www.apexlabs.com.au | Phone: 02 4372 1661 | Fax: 02 4372 1668 (International +61) | Email: info@apexlabs.com.au

Source: http://www.apexlabs.com.au/veterinary/MSDS/43/Pred-X+Anti-Inflammatory+Anti-Allergy++5mg+%26+20mg+Tablets/pdf

SECTION XIV Transport Information

SECTION XV Regulatory Information

SECTION XVI Other Information

Key to Abbreviations

18-12-2018

Apo-Prednisone 5 mg Tablet (2018-12-18)

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FDA - U.S. Food and Drug Administration

9-11-2018

Safety assessment of the substance Ln 1,4‐benzene dicarboxylic acid (with Ln = La, Eu, Gd, Tb) for use in food contact materials

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Europe - EFSA - European Food Safety Authority Publications

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Promise Pharmacy Issues Voluntary Nationwide Recall of Prednisolone and Gatifloxacin Ophthalmic Solution 1%/0.5% Sterile Due to Small Particulate Floating in the Solution

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FDA - U.S. Food and Drug Administration

27-9-2018

Oscor Inc. Issues Recall of TB – Temporary Bipolar Pacing Lead (Unshrouded 2 mm Pins Models)

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During the use of some TB - Temporary Bipolar Pacing Leads, featuring the 2mm unshrouded connectors, the connector cap housing (see Picture 1, No. 2 Pin Cap and Cover) may slide and potentially expose the connection wire. In some instances, this may cause the wire to be more susceptible to loss of connectivity or breakage during movement of the cables causing interruption of the pacing system. The analysis of the returned devices attributed the failure to a design change of the cap housing of the pins. ...

FDA - U.S. Food and Drug Administration

23-11-2018

.@US_FDA issues Class I Medical Device Recall, the most serious type of   recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to  Connector Separation Causing Potential for Loss of Pacing. Find out  more:  https://go.usa.gov/xPHxF  #FDA #MedicalDe

.@US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDe

. @US_FDA issues Class I Medical Device Recall, the most serious type of recall: Oscor Recalls TB Temporary Bipolar Pacing Leads Due to Connector Separation Causing Potential for Loss of Pacing. Find out more: https://go.usa.gov/xPHxF  #FDA #MedicalDevice pic.twitter.com/negJ6HU4x2

FDA - U.S. Food and Drug Administration