INOMAX Inhalation gas (2018)
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Περιεχόμενα
Name of the medicinal product
INOmax 800 ppm mol/mol 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 ...
Pharmaceutical form
Inhalation gas.
Therapeutic indications
INOmax, in conjunction with ventilatory support and other appropriate active substances, is indicated: for the treatment of newborn infants ≥34 weeks gestation with hypoxic respiratory failure associated ...
Posology and method of administration
Persistent Pulmonary Hypertension in the Newborn (PPHN) Prescription of nitric oxide should be supervised by a physician experienced in neonatal intensive care. Prescription should be limited to those ...
Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1. Neonates known to be dependent on right-to-left, or significant left-to-right, shunting of blood.
Special warnings and precautions for use
Inadequate response If it is judged that clinical response is inadequate at 4-6 hours after starting INOmax, the following should be considered. For patients who are to be referred to another hospital, ...
Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed. A clinically significant interaction with other medicinal products used in the treatment of hypoxic respiratory failure cannot be excluded based on the available ...
Fertility, pregnancy and lactation
There are no adequate data from the use of nitric oxide in pregnant women. The potential risk for humans is unknown. It is unknown whether nitric oxide is excreted in human milk. INOmax should not be used ...
Effects on ability to drive and use machines
Not relevant.
Undesirable effects
Summary of safety profile Abrupt discontinuation of the administration of inhaled nitric oxide may cause rebound reaction; decrease in oxygenation and increase in central pressure and subsequent decrease ...
Overdose
Overdose with INOmax will be manifest by elevations in methaemoglobin and NO<sub>2</sub>. Elevated NO<sub>2</sub> may cause acute lung injury. Elevations in methaemoglobinaemia reduce the oxygen delivery ...
Pharmacodynamic properties
Pharmacotherapeutic group: Other respiratory system products ATC code: R07AX01 Nitric oxide is a compound produced by many cells of the body. It relaxes vascular smooth muscle by binding to the haeme moiety ...
Pharmacokinetic properties
The pharmacokinetics of nitric oxide has been studied in adults. Nitric oxide is absorbed systemically after inhalation. Most of it traverses the pulmonary capillary bed where it combines with haemoglobin ...
Preclinical safety data
Effects in non-clinical studies were observed only at exposures considered sufficiently in excess of the maximum human exposure indicating little relevance to clinical use. Acute toxicity is related to ...
List of excipients
Nitrogen
Incompatibilities
In the presence of oxygen NO rapidly forms NO<sub>2</sub>, see section 4.5.
Shelf life
Shelf life: 3 years.
Special precautions for storage
All regulations concerning handling of pressure vessels must be followed. Store gas cylinders indoors in well-ventilated rooms or outdoors in ventilated sheds where they are protected from rain and direct ...
Nature and contents of container
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 ...
Special precautions for disposal and other handling
Instructions for use/handling INOmax When connecting an INOmax cylinder to the delivery system, always secure that the cylinder concentration is of the same concentration for which the system is configured. ...
Marketing authorization holder
Linde Healthcare AB, SE-181 81 Lidingö, Sweden
Marketing authorization number(s)
EU/1/01/194/003 EU/1/01/194/004
Date of first authorization / renewal of the authorization
Date of first authorisation: 01/08/2001 Date of last renewal: 01/06/2006
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