NEOPHYR Medicinal gas, compressed Ref.[49856] Active ingredients: Nitric oxide (NO)

Source: Health Products Regulatory Authority (IE)  Revision Year: 2018  Publisher: SOL S.p.A., Via Borgazzi 27, 20900 Monza, Italy

Product name and form

Neophyr 225 ppm mol/mol, medicinal gas, compressed.

Pharmaceutical Form

Medicinal gas, compressed.

Colourless and odourless gas.

Qualitative and quantitative composition

Nitric oxide 225ppm mol/mol.

Nitric oxide (NO) 0.225 ml in Nitrogen (N2) 999.775 ml.

A 10-liter gas cylinder filled to 150 bar supplies 1500 lof gas at a pressure of 1 bar at 15°C.

For the 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

Gas cylinders with a capacity of 10l.

A 10-liter gas cylinder filled to 150 bar contains about 1.77 kg of gas. Aluminum alloy cylinders have a white painted body and a turquoise-painted shoulder.

They are equipped with a stainless steel residual pressure valve with a specific ISO 5145 (2004) type outlet connector.

Marketing authorization holder

SOL S.p.A., Via Borgazzi 27, 20900 Monza, Italy

Marketing authorization dates and numbers

PA1848/001/003

Date of First Authorisation: 12th April 2013
Date of last renewal: 16th February 2017

Drugs

Drug Countries
NEOPHYR Spain, Croatia, Ireland, Romania

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