SUMMARY OF PRODUCT CHARACTERISTICS
Spc-airsynth-may2009 1
1. NAME OF THE MEDICINAL PRODUCT
Air medicinal synthetic AIR PRODUCTS, 22% v/v, medicinal gas, compressed
2. QUALITATIVE AND QUANTITATIVE COMPOSITION
Oxygen 22% v/v For the full list of excipients, see section 6.1
3. PHARMACEUTICAL FORM
Medicinal gas, compressed
Air medicinal synthetic AIR PRODUCTS is a colourless, odourless and tasteless gas.
4. CLINICAL PARTICULARS
4.1 Therapeutic indications
Prevention of hypoxia.
4.2 Posology and method of administration
Posology The flow and duration of the application has to be determined in accordance with the cause of the hypoxia.
Method of administration The method of administration will vary in accordance with the cause of the hypoxia.
Humidification is advised during long-term application.
Air medicinal synthetic AIR PRODUCTS is administered through inhaled air, preferably with use of special equipment (For example: nose catheter or a facial mask, face tents, crib tents or a supply pipe to a tracheotomy. The device must be operated as described by the manufacturer. With this equipment the Air medicinal synthetic AIR PRODUCTS is administered through inhaled air. Any excess oxygen leaves the body through exhalation and mixes with the ambient air (the “non-rebreathing” system). During anaesthesia, special systems with a rebreathing reservoir or circulation systems are used in which the exhaled air is inhaled once again (“rebreathing” system). If the patient is unable to breathe independently, artificial mechanical ventilation may be applied.
4.3 Contraindications
There are no absolute contraindications.
4.4 Special warnings and precautions for use
Air medicinal synthetic AIR PRODUCTS should only be administered to patients at atmospheric pressure. The administration of Air medicinal synthetic AIR PRODUCTS under pressure may cause caisson disease (as a result of nitrogen effects) and oxygen toxicity.
If Air medicinal synthetic AIR PRODUCTS is mixed with other inhalation gases, the oxygen fraction in the inhaled gas mixture (Fraction of inspired Oxygen - FiO2) must be kept at 21% at least. In
Spc-airsynth-November 2019 2
practice, this means that, if it is a component of a gas mixture, oxygen must be one of the other components.
During use at exceptionally high flow rates, as with use in an incubator, Air medicinal synthetic AIR PRODUCTS may feel cold.
Follow your supplier’s instructions, especially as regards the following:
• The gas cylinder cannot be used if it is visibly damaged or is suspected of having been damaged or exposed to extreme temperatures. • All contact with oil, grease or other hydrocarbons must be avoided. • Only equipment suitable for the specific type of gas cylinder and gas may be used. • No pliers or other tools may be used to open or close the cylinder valve, to prevent the risk of damage. • The shape of the container must not be altered. • In the event of a leak, the cylinder valve must be closed immediately, if it is safe to do so. If the valve cannot be closed, the gas cylinder must be taken to a safe place outdoor to allow the oxygen to flow out • The valves of empty gas cylinders must be closed. • The siphoning of gas under pressure is not permitted. • Keep the container away from naked flames. • Do not smoke during use of Medicinal Air.
General Clean and dry connections for hoses, valves etc. are important. If dirty, cleaning of connections should take place in accordance with the supplier’s instructions. It is recommended not to use any solvents, oil or grease on the cylinder valve or the associated equipment.
4.5 Interaction with other medicinal products and other forms of interaction
No interactions with Air medicinal synthetic AIR PRODUCTS have been reported. Below, the interactions with 100% v/v oxygen are reported. It is not known whether these also play a role in Air medicinal synthetic AIR PRODUCTS (oxygen 22% v/v).
Interactions of oxygen with amiodarone have been reported. Relapse of lung damage induced by bleomycin or actinomycin may have a fatal outcome. Patients with pre-existing oxygen radical damage to the lung may have this damage exacerbated by oxygen therapy, for example in the treatment of paraquat poisoning. Respiratory depression due to alcohol may aggravate by oxygen. Medicines with known adverse interaction are: adriamycin, menadion, promazin, chloorpromazine, thioridazin and chloroquine. In tissue with a high concentration of oxygen, in particular the lungs, these effects will be more pronounced. The toxicity of oxygen may be enhanced by corticosteroids, sympathicomimetics, or x- rays. Moreover, the toxicity of oxygen may be enhanced in hyperthyroidism, or deficiency of vitamin C or E, or glutathione.
4.6 Fertility, pregnancy and lactation
Air medicinal synthetic AIR PRODUCTS may be used during pregnancy and breast-feeding.
4.7 Effects on ability to drive and use machines
Air medicinal synthetic AIR PRODUCTS has no influence on the ability to drive or use machines.
4.8 Undesirable effects
Spc-airsynth-November 2019 3
There are no known undesirable effects.
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 national reporting system listed in Appendix V.
4.9 Overdose
Not applicable, although the administration of Air medicinal synthetic AIR PRODUCTS under pressure may cause caisson disease (as a result of nitrogen effects) and oxygen toxicity (also see section 4.4).
5. PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group: medical gases, ATC code: V03AN05
Air medicinal synthetic AIR PRODUCTS provides an alternative air source that can be of use if special requirements are to be met with regard to purity; synthetic air is a mixture of pharmaceutical oxygen and pharmaceutical nitrogen and therefore does not contain any impurities and contaminations, as in compressed environmental air.
5.2 Pharmacokinetic properties
Inhaled oxygen is absorbed by a pressure-dependent gas exchange between alveolar gas and the capillary blood passing through the alveoli. The oxygen is transported to all tissues of the body (mainly bound to haemoglobin) by the systemic circulation. Only a very small portion is free oxygen (dissolved in plasma). Oxygen is an essential component of the intermediate metabolism of the cell for the creation of energy – aerobic ATP production in de mitochondria. The oxygen that is absorbed by the body is almost entirely excreted in the form of carbon dioxide that is produced in this intermediate metabolism.
5.3 Preclinical safety data
As this product is similar to normal air in the atmosphere no special risks for human health are expected.
6. PHARMACEUTICAL PARTICULARS
6.1 List of excipients
Nitrogen 78% v/v
6.2 Incompatibilities
Not applicable.
6.3 Shelf life
3 years
Spc-airsynth-November 2019 4
6.4 Special precautions for storage
• Store between – 20°C and + 65°C. • Store in vertical position. • Store in a well ventilated room. • Keep away from inflammable products. • Protect from falling and other impacts. • Cylinders containing a different type of gas should be stored separately. • Full and empty gas cylinders should be stored separately. • Gas cylinders must not be stored near sources of heat. • Store covered and well-protected against the effects of the weather.
6.5 Nature and contents of container
Air medicinal synthetic AIR PRODUCTS is stored under pressure in gas cylinders. The valves are made of brass. The colour of the cylinder body is white and for the shoulder is blackband on white. Gas cylinders with a capacity of x litres provide y (unit of volume) Air medicinal synthetic AIR PRODUCTS at 15°C and 1 bar.
Gas cylinders – Filling pressure 200bar, Air medicinal synthetic AIR PRODUCTS Volume (x) in litres 0.5 1 2 3 4 5 7 10 13 No. of litres air (y) 97 193 387 580 774 967 1354 1935 2515
800 900 Volume (x) in litres 15 20 25 30 40 50 (16x50l) (18x50l) No. of litres air (y) 2902 3869 4836 5804 7738 9673 154768 174114
Gas cylinders – 200bar – Air medicinal synthetic AIR PRODUCTS (See note (1)) Volume (x) in litres 0.5 1 2 3 4 5 7 10 13 Gas cylinder material and type s,a & s,a & s,a & s,a & s,a & s,a & s,a & of valve p,h,i p,h,i p,h,i p,h,i p,h,i p,h,i s,a & p,h,i s,a & p,h,i p,h,i
800 900 Volume (x) in litres 15 20 25 30 40 50 (16x50l) (18x50l) Gas cylinder material and type s,a & s,a & s,a & of valve p,h,i p,h,i p,h,i s & p,h s & p,h s & p,h s & h s & h
Note (1): s: Steel gas cylinder a: Aluminium or aluminium-with-coating gas cylinder p: Pin-index valve h: Manual valve i: Integrated valve
Not all pack sizes may be marketed.
6.6 Special precautions for disposal and other handling
Close the valves of the cylinders. Return the cylinder to the supplier when empty.
Spc-airsynth-November 2019 5
7. MARKETING AUTHORISATION HOLDER
To be completed nationally.
8. MARKETING AUTHORISATION NUMBER(S)
To be completed nationally.
9. DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
To be completed nationally.
10. DATE OF REVISION OF THE TEXT
To be completed nationally.
Spc-airsynth-November 2019 6