Summary of medicine characteristics - MEDICAL HELIUM
1 NAME OF THE MEDICINAL PRODUCT
Medical Helium
2 QUALITATIVE AND QUANTITATIVE COMPOSITION
The specification for Medical Helium is:
Helium
> 99.95 %
Medicinal gas, compressed
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
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
5.3 Preclinical safety dataThe current published toxico-pharmacological data indicates that Helium will not be harmful to humans when administered with at least 21% Oxygen.
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
7 MARKETING AUTHORISATION HOLDER
8 MARKETING AUTHORISATION NUMBER(S)
PL 00735 / 5008R
9 DATE OF FIRST AUTHORISATION/RENEWAL OF THEAUTHORISATION
21/11/2016