Medical Helium
SUMMARY OF PRODUCT CHARACTERISTICS
1 NAME OF THE MEDICINAL PRODUCT
Medical Helium
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The specification for Medical Helium is:
Helium > 99.95 %
3 PHARMACEUTICAL FORM
Medicinal gas, compressed
4 CLINICAL PARTICULARS
4.1 Therapeutic indications
Because of its low density, Helium flows through an orifice much more easily than other medical gases.
Helium is used with at least 21% Oxygen in the following circumstances:
• To assist the flow of Oxygen into the alveoli of patients with severe respiratory obstruction
• To prevent atelectasis
In various concentrations, in conjunction with Air or Oxygen, for gas transfer lung function tests.
4.2 Posology and method of administration
There is no distinction generally between the use of helium in different age groups
In its role as a carrier for Oxygen, Helium is administered through the lungs by inhalation with 21% Oxygen or higher concentrations by mask or endotracheal tube.
4.3 Contraindications
None applicable
4.4 Special warnings and precautions for use
Helium should never be used with less than 21% Oxygen.
Helium will diffuse through rubber tubing.
Care is needed with the use and handling of Medical Helium (see section 6.6).
4.5 Interaction with other medicinal products and other forms of interaction
None Applicable
4.6 Fertility, pregnancy and lactation
Medical Helium does not adversely affect pregnancy and lactation.
4.7 Effects on ability to drive and use machines
In normal circumstances, Medical Helium does not affect ability to drive or to operate machinery.
4.8 Undesirable effects
With Helium, the only undesirable effect will result from less than 21% Oxygen being given with the Helium when, with decreasing Oxygen levels, asphyxia will result.
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 System www.mhra.gov.uk/yellowcard
4.9 Overdose
Other than the condition detailed in 4.8 ‘Undesirable Effects’, there are no other overdose issues with Medical Helium.
5 PHARMACOLOGICAL PROPERTIES
5.1 Pharmacodynamic properties
Pharmacotherapeutic group Medical Gas
ATC Code V03AN03
The characteristics of Helium are:
Inert colourless gas Molecular weight 4.00 Boiling point -269OC (at 1 bar(g))
Density 0.169 kg/m3 (at 15OC)
Helium has no physiological activity and will not support life.
5.2 Pharmacokinetic properties
Helium has a low co-efficient of solubility and a high rate of diffusion compared with Nitrogen.
It is completely inert and non-toxic
When Helium replaces the Nitrogen in Air, the specific gravity of the resultant Helium / Oxygen (79:21) mixture is 341 (compared with Air at 1000).
This mixture flows through the bronchi three times more easily than Air.
In patients with respiratory obstruction, therefore, more Oxygen may be presented to the alveoli for the same ventilatory effort.
The absorption of Helium from the alveoli is very slow. Inhalation of Helium may be used to prevent atelectasis.
5.3 Preclinical safety data
The current published toxico-pharmacological data indicates that Helium will not be harmful to humans when administered with at least 21% Oxygen.
6 PHARMACEUTICAL PARTICULARS
6.1 List of excipients
None
6.2 Incompatibilities
Medical Helium is chemically inactive and will not react with other compounds at normal temperatures.
6.3 Shelf life
36 months
6.4 Special precautions for storage
Medical Helium cylinders should be:
• stored in a designated under cover medical gas cylinder storage area which should be preferably inside, kept dry and clean and not subjected to extremes of heat or cold.
• not stored near stocks of combustible materials or near sources of heat.
• used in strict rotation.
• stored vertically.
• stored separately from industrial and other non-medical cylinders.
• full and empty cylinders should be stored separately.
• medical cylinders containing different gases should be segregated within the store
• warning notices prohibiting smoking and naked lights must be posted clearly.
• emergency services should be advised of the location of the cylinder store.
• cylinders must not be repainted, have any markings obscured or labels removed
• protected from theft.
6.5 Nature and contents of container
Medical Helium Cylinder and Valve Details
Medical Helium cylinders are manufactured from steel with a design working pressure of at least 137 bar(g) at 15OC.
The cylinder valves are constructed from high tensile brass with a steel spindle fitted with a Nylon 6.6 insert.
A summary of Medical Helium cylinders, their size, capacity and construction, type of valve fitted and valve outlet pressure is detailed below:
|
Cylinder Size |
Water Capacity (litres) |
Gas Content (litres) |
Cylinder Construction |
Valve Outlet Connection |
Cylinder Pressure bar(g) |
|
F |
9.3 |
1200 |
Steel |
BS 341 No.3 Top Outlet fitted with MPR device |
137 |
6.6 Special precautions for disposal General
All personnel handling Medical Helium gas cylinders should have adequate knowledge of the:
• properties of the gas
• precautions to be taken when storing, handling and using the cylinders,
• actions to be taken in the event of an emergency,
• correct operating procedures for their use.
Preparation for Use
Prior to using Medical Helium cylinders, ensure that:
• an appropriate medical gas regulator (with a design pressure of at least 137 bar(g)) is fitted. A regulator with BS 341 No.3 inlet connector must be used.
• the connecting face on the regulator is clean and the ‘O’ ring / seal fitted is in good condition.
• the cylinder valve is opened slowly
• the cylinder valves and any associated equipment used to deliver the gas to the patient is not lubricated and kept free from oil and grease.
Where moisturising creams are required for use with the face mask, only an approved cream should be used and under no circumstances should oil based creams be used.
Leaks
Having connected the regulator to the Medical Helium cylinder check the connections for leaks using the following procedure:
• Should leaks occur this will usually be evident by a hissing noise.
• Leaks can be found by brushing the suspected area with an approved leak test solution such as 1% Teepol HB7 solution.
• Should a leak occur between the valve outlet and the regulator, depressurise and remove the regulator and fit a new ‘O’ ring. Reconnect the regulator to the valve with moderate force only. If the leak persists, fit a replacement regulator.
• Sealing or joining compounds must never be used to cure a leak.
• Never use excessive force when connecting equipment to cylinders.
Use of Cylinders
When Medical Helium cylinders are in use ensure that they are:
• handled with care and not knocked violently or allowed to fall.
• only moved with the appropriate size and type of trolley or handling device.
• firmly secured to a suitable cylinder support when in use.
• only used for medicinal purposes.
• not used in the vicinity of persons smoking or near naked lights.
After use cylinder valves should be closed using moderate force only and the pressure in the regulator released.
When the Medical Helium cylinder is empty ensure that:
• the cylinder valve is closed using moderate force only and the pressure in the regulator or tailpipe released.
• the valve outlet cap, where fitted, is replaced
• the empty cylinders are immediately returned to the empty cylinder store for return to BOC.
7 MARKETING AUTHORISATION HOLDER
BOC Ltd.
The Priestley Centre 10 Priestley Road The Surrey Research Park GUILDFORD Surrey, GU2 7XY.
8 MARKETING AUTHORISATION NUMBER(S)
PL 00735 / 5008R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THE AUTHORISATION
21/11/2016
10 DATE OF REVISION OF THE TEXT
21/11/2016