Pharmaceutical particulars : מידע רוקחי

6. PHARMACEUTICAL PARTICULARS

6.1 List of excipients
Nitrogen

6.2 Incompatibilities

In the presence of oxygen NO rapidly forms NO2, see section 4.5.
6.3 Shelf life

12 months

6.4 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 sunlight.
Protect the gas cylinders from shocks, falls, oxidising and flammable materials, moisture, sources of heat or ignition.
Storage in the pharmacy department
The gas cylinders should be stored in an airy, clean and locked place, for storage of medicinal gas only. Inside this place, a separate premise should be dedicated to the storage of nitric oxide gas cylinders.
Storage in the medical department
The gas cylinder should be put in an equipped site with appropriate material in order to hold the gas cylinder vertically.
Transport of gas cylinders
The gas cylinders should be transported with appropriate material in order to protect them from risks of shocks and falls.
During inter- or within-hospital transfers of patients treated with Mixture NO 800 ppm, the gas cylinders should be fixedly stowed away in order to hold the gas cylinders vertically and to avoid the risk of fall or untimely modifying output. A particular attention should be also turned to the fastening of the pressure regulator so as to avoid the risks of accidental failures.
6.5 Nature and contents of container


Drug Product           Mixture NO 800 ppm in nitrogen
Size cylinders                5-50 liter

Pressure                 120-150 bar
Material of                Aluminum construction
Cylinder Valve           CGA 660/CGA330

6.6 Special precautions for disposal and other handling

Instructions for use/handling Mixture NO 800 ppm in Nitrogen
When connecting a Mixture NO 800 ppm in Nitrogen cylinder to the delivery system, always secure that the cylinder concentration is of the same concentration for which the system is configured.
In order to avoid all incidents, the following instructions should be absolutely respected - the good condition of the material should be checked before use
- the gas cylinders should be fixedly stowed away in order to avoid untimely fall - the valve should be fully open when used but not be opened with violence - a defective valve should neither be used nor be repaired. Return to distributor /manufacturer - a gas cylinder whose valve is not protected by a cap or a shell should not be used - the pressure regulator should be purged by the nitrogen-nitric oxide mixture before each new use in order to preclude nitrogen dioxide inhalation
- the pressure regulator should not be tightened with pliers, at the risk of crushing the gasket All equipment, including connectors, tubing, and circuits, used in the delivery of nitric oxide must be made of materials compatible with the gas. Among metallic construction materials, only stainless steel can be recommended.
There is in general no need for scavenging of excess gas, the work place ambient air quality should however be considered and trace concentrations of NO or NO2/NOx must not exceed set national occupational exposure limits. Accidental exposure to Mixture NO 800 ppm in Nitrogen in hospital staff has been associated with adverse events (see section 4.8).
Instruction for disposal of gas cylinder
When the gas cylinder is empty, it should not be discarded. Empty gas cylinders will be collected by the supplier.