INOMAX Inhalation gas Ref.[8674] Active ingredients: Nitric oxide (NO)

Source: European Medicines Agency (EU)  Revision Year: 2018  Publisher: Linde Healthcare AB, SE-181 81 Lidingö, Sweden

Product name and form

INOmax 800 ppm mol/mol inhalation gas.

Pharmaceutical Form

Inhalation gas.

Qualitative and quantitative composition

Nitric oxide (NO) 800 ppm mol/mol.

A 2 litre gas cylinder filled at 155 bar absolute brings 307 litres of gas under pressure of 1 bar at 15°C.

A 10 litre gas cylinder filled at 155 bar absolute brings 1535 litres of gas under pressure of 1 bar at 15°C.

For a full list of excipients, see section 6.1.

Active Ingredient Description
Nitric oxide (NO)

Nitric oxide is a compound produced by many cells of the body. It relaxes vascular smooth muscle by binding to the haeme moiety of cytosolic guanylate cyclase. When inhaled, nitric oxide produces selective pulmonary vasodilation.

List of Excipients

Nitrogen

Pack sizes and marketing

Pack sizes:

A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.

A 2 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.

A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a standard valve hand-wheel.

A 10 litre aluminium gas cylinder (identification with aquamarine shoulder and white body) filled under a pressure of 155 bar, equipped with a stainless steel positive pressure (residual) valve with a specific outlet connection and a INOmeter device equipped valve hand-wheel.

Marketing authorization holder

Linde Healthcare AB, SE-181 81 Lidingö, Sweden

Marketing authorization dates and numbers

EU/1/01/194/003
EU/1/01/194/004

Date of first authorisation: 01/08/2001
Date of last renewal: 01/06/2006

Drugs

Drug Countries
INOMAX Canada, Cyprus, Ecuador, Estonia, Spain, Finland, France, Croatia, Ireland, Italy, Lithuania, Poland, Romania, United States

© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.