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SPC: ΙΝΟΜΑΧ Inhalation gas (2018)

Αναφορές

Βιβλιογραφική αναφορά

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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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