INOmax

Ikaria Australia Pty Ltd

Revision date : 2019-10-31

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GHS04
Health risk rating 1
Safety risk rating 1
Environmental risk rating 1

Note: Ingredients listed on restricted chemical lists

EC/CAS

7727-37-9

Name of the chemical

Nitrogen N2

Concentration

N/A

General Information

Revision date

2019-10-31

Product name

INOmax

Product Synonyms

INOmax® (800 ppm) * Nitric Oxide (0.08%) Blended with Nitrogen (99.92%) * INOflo®

supplier name

Ikaria Australia Pty Ltd

Manufacturer Name

Mallinckrodt Manufacturing LLC

Icons in SDS

GHS04 T019

Company Information

company name

Ikaria Australia Pty Ltd

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

Brands.SDS@mnk.com

GHS Information

Signal word

Warning

Section 2

Physical hazards

Not classified. Eealth hazards Specific target organ toxicity following single Category 1 (blood, lung) exposure

Environmental hazards

Not classified. Label elements, including precautionary statements Eazard symbol(s) Gas cylinder

Signal word

Warning Eazard statement(s) Contains gas under pressure; may explode if heated.

Prevention

Do not handle until all safety precautions have been read and understood. Keep container tightly closed. Use only outdoors or in a well-ventilated area. Wear respiratory protection.

Response

IF exposed: Call a POISON CENTRE or doctor/physician.

Storage

Store locked up.

Disposal

Dispose of contents/container in accordance with local/regional/national/international regulations.

Other hazards which do not result in classification

May displace oxygen and cause rapid suffocation. Exposure to rapidly expanding gas or vapourizing liquid may cause frostbite ("cold burn"). Exposure may aggravate those with pre-existing eye, skin, or respiratory conditions. Those with pre-existing heart, lung, or blood disorders may be more susceptible to the symptoms of asphyxia. Nitric oxide converts to nitrogen dioxide when exposed to air. Used in the treatment of prescribed medical disorders. Administration of this gas mixture may be hazardous or contraindicated. Use only under the supervision of an experienced licensed practitioner familiar with the indications for use, dosages, methods, hazards, contraindications, and side effects.

Additional information

The hazard warnings associated with this product are based on the individual ingredients included in the finished dosage form of the pharmaceutical product. The supplied package insert (approved labeling) provides the necessary drug safety information. All Mallinckrodt finished products are labeled in compliance with the requirements of the Food and Drug Administration (FDA) and must be used in the prescribed manner. Each package of the finished pharmaceutical product is supplied with a package insert (approved labeling) which provides necessary drug safety information.

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