SUMMARY OF PRODUCT CHARACTERISTICS
1.NAME OF THE MEDICINAL PRODUCT
Air 21% v/v inhalation gas
2.QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxygen 20.95% v/v.
Each dose of 500 ml contains approximately 105 ml of oxygen.
For the full list of excipients, see section 6.1.
3.PHARMACEUTICAL FORM
Inhalation gas.
A colourless, odourless gas.
4.CLINICAL PARTICULARS
4.1Therapeutic indications
Air is indicated for respiration in adults, adolescents, children, infants and neonates. It is also indicated for speech.
4.2Posology and method of administration
Posology
The recommended dose is 12 to 20 breaths per minute at rest, each of approximately 500 ml, giving a minute volume of 6 to 10 litres. During strenuous exercise the rate rises to approximately 35 to 50 breaths per minute and the volume of each breath to 2 to 3 litres.
No dose adjustment is required on the basis of body weight, renal impairment or hepatic impairment.
Paediatric population
The respiratory rate is higher in younger patients: approximately 30 to 60 breaths per minute in neonates, 30 to 40 in infants, and 20 to 30 in children. Administration begins spontaneously within approximately ten seconds of birth.
Method of administration
For inhalation use. Air is administered by the nasal or oral route. The nasal route is preferred, as the nasal passages warm, humidify and filter each dose.
4.3Contraindications
Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.
Submersion.
Altitudes above approximately 8,000 m without supplementary oxygen.
Detectable odour of combustion, fuel or solvent.
4.4Special warnings and precautions for use
The partial pressure of oxygen falls with barometric pressure. At 3,000 m each dose contains approximately 30% less oxygen than at sea level, and minute volume increases to compensate. Acclimatisation should be considered above approximately 2,500 m.
Air is not sterile. It contains variable quantities of particulate matter, pollen, fungal spores, sea salt, soot and bacteria, typically 104 to 106 bacterial cells per cubic metre over land.
4.5Interaction with other medicinal products and other forms of interaction
No interaction studies have been performed.
Medicinal products for inhalation are administered in Air.
4.6Fertility, pregnancy and lactation
Pregnancy
Air should be administered throughout pregnancy. Tidal volume increases by approximately 30 to 40% from early gestation, and minute volume by 20 to 40% at term. A sensation of breathlessness is reported by 60 to 70% of patients in the third trimester and is not, in itself, an indication of inadequate administration.
Breast-feeding
Air should be administered throughout breast-feeding. It is administered concurrently to the infant.
Fertility
No data available.
4.7Effects on ability to drive and use machines
Air has no or negligible influence on the ability to drive and use machines.
4.8Undesirable effects
Adverse reactions are listed below by frequency, defined as: very common (≥1/10); common (≥1/100 to <1/10); uncommon (≥1/1,000 to <1/100); rare (≥1/10,000 to <1/1,000); very rare (<1/10,000).
Respiratory, thoracic and mediastinal disorders
Very common: yawning, sneezing, hiccups, snoring, rhinorrhoea on exposure to cold air, seasonal allergic rhinitis.
Injury, poisoning and procedural complications
Very rare: decompression sickness, where Air has been administered under raised pressure and the pressure subsequently reduced at an excessive rate.
Reporting of suspected adverse reactions
Reporting suspected adverse reactions after authorisation of the medicinal product is important. It allows continued monitoring of the benefit/risk balance of the medicinal product. Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store.
4.9Overdose
An increased rate or depth of administration reduces the arterial partial pressure of carbon dioxide, producing light-headedness, paraesthesia and carpopedal spasm. The condition is self-limiting. Management is to reduce the rate of administration.
5.PHARMACOLOGICAL PROPERTIES
5.1Pharmacodynamic properties
Pharmacotherapeutic group: medical gases, ATC code: V03AN05
Mechanism of action
Oxygen diffuses from the alveolus into pulmonary capillary blood down a partial pressure gradient of approximately 13.3 kPa (100 mmHg) alveolar to 5.3 kPa (40 mmHg) mixed venous, and is carried predominantly bound to haemoglobin, which binds approximately 1.34 ml of oxygen per gram. Carbon dioxide diffuses in the opposite direction and is eliminated in the exhaled dose.
Pharmacodynamic effects
Oxygen consumption at rest is approximately 250 ml per minute and carbon dioxide production approximately 200 ml per minute, a respiratory quotient of 0.8. Exhaled Air contains approximately 16% oxygen and 4% carbon dioxide.
Clinical efficacy and safety
No randomised, placebo-controlled trials have been conducted.
5.2Pharmacokinetic properties
Absorption
Absorption is by passive diffusion across the alveolar membrane and is complete within the duration of a single breath. Approximately 150 ml of each 500 ml dose remains in the conducting airways and does not reach the alveoli.
Distribution
Distribution is by the systemic circulation, bound to haemoglobin. The circulation time from lung to peripheral tissue is of the order of 20 seconds.
Biotransformation
Oxygen is consumed in oxidative phosphorylation and is not recovered unchanged. Nitrogen and argon, which together constitute approximately 79% of the dose, are pharmacologically inert and are exhaled unchanged.
Elimination
Elimination is pulmonary, as carbon dioxide and water vapour. The nitrogen and argon fraction, approximately 79% of each dose, is eliminated unchanged within the same breath.
5.3Preclinical safety data
No preclinical safety studies have been conducted with Air. Every species in which any medicinal product has been studied was maintained in Air throughout.
6.PHARMACEUTICAL PARTICULARS
6.1List of excipients
Nitrogen (78.08% v/v)
Argon (0.93% v/v)
Carbon dioxide (0.043% v/v)
Neon, helium, methane, krypton, hydrogen, xenon (traces)
Water vapour (0 to 4% v/v)
6.2Incompatibilities
Not applicable.
6.3Shelf life
Not applicable. Air is continuously regenerated by plants, algae and cyanobacteria and does not carry an expiry date.
6.4Special precautions for storage
This medicinal product does not require any special storage conditions.
6.5Nature and contents of container
Air is retained by gravity against the surface of the Earth. The container is not sealed and its upper boundary is not defined. Pack size 5.15 × 1018 kg, of which approximately 75% lies below an altitude of 10 km.
Pack size: 1. Not all pack sizes may be marketed.
6.6Special precautions for disposal and other handling
No special requirements for disposal. Used Air should be exhaled.
7.MARKETING AUTHORISATION HOLDER
None.
8.MARKETING AUTHORISATION NUMBER(S)
None.
9.DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
Date of first authorisation: approximately 400 million years ago.
Date of latest renewal: continuous.
10.DATE OF REVISION OF THE TEXT
English · Italiano medinfo@inhale.it