Aplisol

drugsafety@parpharm.com

Revision date : 2018-07-17

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GHS08
Health risk rating 5
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

General Information

Version

3.0.0

Revision date

2018-07-17

Product name

Aplisol

Product Synonyms

Tuberculin PPD, Diluted

Chemical name

Mixture - contains tuberculin purified protein derivative

1.2.1 Relevant identified uses

Bulk formulated pharmaceutical mixture product packaged in final form for patient of the substance or

Emergency telephone

+1 (800) 424-9300, +1 (703) 527-3887

Icons in SDS

GHS08

Company Information

company name

drugsafety@parpharm.com

e-mail address of the competent person responsible for the Safety Data Sheet

drugsafety@parpharm.com

GHS Information

Signal word

Danger

Hazard Codes

Hazard statements (CLP)

H317, H334

Hazard statements

Code

Statements

H317

May cause an allergic skin reaction

Section 2

SECTION 2: Hazards identification

WHMIS 2015 Classification of the substance or mixture Drugs in the finished state and intended for the final user are not subject to labeling in the US, EU or Canada. Please consult the prescribing/packaging information. The classification and labeling listed below is for bulk Aplisol® Tuberculin Purified Protein Derivative, Diluted [Stabilized Solution] 5TU/0.1 ml) in multi-dose vials Globally Harmonized System [GHS] Skin sensitizer - Category 1. Respiratory sensitizer - Category 1 HAZARDS IDENTIFICATION …continued

Signal word

Danger

Hazard statements

H334 - May cause allergy or asthma symptoms or breathing difficulties if inhaled. H317 - May cause allergic skin reaction. not be allowed out of the workplace. P280 - Wear eye/face protection. P285 - In case of inadequate ventilation wear respiratory protection. P304 + P340 - IF INHALED: Remove victim to fresh air and keep at rest in a position comfortable for breathing. P342 + P311 - If experiencing respiratory symptoms: Call a POISON CENTER or doctor/physician. P302 + P352 - IF ON SKIN: Wash with plenty of soap and water. P333 + P313 - If skin irritation or rash occurs: Get medical advice/attention. P501 - Dispose of contents/container to location in accordance with local/regional/national/international regulations.

Precautionary statements

P261 - Avoid breathing mist or vapor. P272 - Contaminated work clothing should

2.3 Other hazards

Aplisol (tuberculin PPD, diluted) is a sterile aqueous solution of a purified protein fraction isolated from a human strain of Mycobacterium tuberculosis for intradermal administration as an aid in the diagnosis of tuberculosis. Common adverse effects associated with use include local, as well as, systemic hypersensitivity reactions (redness, rash, swelling, itching, anaphylaxis). In a workplace setting, the likelihood of systemic effects following accidental ingestion is low, due to the rapid breakdown of proteins in the digestive tract. Although purified protein particles are fairly large in size, it is not known if systemic effects can occur following accidental inhalation. Proteins, in general, can cause skin and/or respiratory sensitization. Note This mixture is classified as hazardous under GHS as implemented by Regulation

2.1 Classification of the substance or mixture

Drugs in the finished state and intended for the final user are not subject to substance or mixture

SDS Library

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