→

Medical Gas Data Sheet (MGDS)

Medical helium

BOC: Living healthcare

02 Medical helium Medical Gas Data Sheet Medical helium Medical Gas Data Sheet 03

Summary of Product Characteristics (SPC) 4.6 Pregnancy and lactation Helium does not adversely affect pregnancy and lactation.

4.7 Effects on ability to drive and Not applicable

use machines

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:

HPRA Pharmacovigilance
Earlsfort Terrace
IRL - Dublin 2
Tel: +353 1 6764971
1. Name of the Helium. Fax: +353 1 6762517
medicinal product Website: www.hpra.ie
e-mail: [email protected]

2. Qualitative and Medical helium cylinders are supplied to the following specification: 4.9 Overdose As detailed in 4.8 above.
quantitative composition Helium 99.5%

The Medical Helium cylinder specification complies with the current European Pharmacopoeia monograph 5. Pharmacological Pharmacotherapeutic Group – Medical gas
(2155). properties ATC Code – V03AN03

5.1 Pharmacodynamic properties The characteristics of helium are:

3. Pharmaceutical form Medicinal gas, compressed. • inert, odourless, colourless gas
• Molecular weight 4.00
• Boiling point -269ºC (at 1 bar)
4. Clinical particulars • Density 1.169 kg/m3 (at 15ºC).

4.1 Therapeutic indications Because of its low density helium flows through an orifice much more easily than other medical gases. Helium has no physiological activity and will not support life.

Helium is used with a least 21% oxygen in the following circumstances: 5.2 Pharmacokinetic properties Helium has a low coefficient of solubility and high rate of diffusion compared with nitrogen. It is completely
• To assist the flow of oxygen into the alveoli of patients with severe respiratory obstruction inert and non-toxic. When helium replaces the nitrogen in air, the specific gravity of the resultant helium/
• To prevent atelectasis oxygen (79:21) mixture is 341 (compared with air at 1000). This mixture flows through bronchi three times
• In various concentrations, in conjunctions with air or oxygen, for gas transfer lung function tests. more easily then 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 alveoli is very slow. Inhalation of
4.2 Posology and method of There is no distinction generally between the use of helium in age groups. In its role as a carrier for oxygen, helium may be used to prevent atelectasis.
administration helium is administered through the lungs by inhalation with 21% or higher concentrations of oxygen by
mask or endotracheal tube. Cylinders should only be used in conjunction with medical helium gas pressure 5.3 Preclinical safety data Not applicable
regulators, although medical oxygen gas pressure regulators may be used on the F-size helium cylinders.

4.3 Contraindications Not applicable. 6. Pharmaceutical

particulars
4.4 Special warnings and Helium should never be used with less than 21% oxygen.
precautions for use 6.1 List of excipients None
Helium will diffuse through rubber tubing.
6.2 Incompatibilities Medical Helium is highly dangerous when in contact with oils, gases, tarry substances and many plastics due
Care is needed in the handling and use of medical helium gas cylinders. to the risk of spontaneous combustion with high pressure gases.

4.5 Interaction with other Not applicable 6.3 Shelf life 1 year.
medicinal products and other
forms of interaction

Reproduction without permission is strictly prohibited Reproduction without permission is strictly prohibited
© BOC Limited 2015 © BOC Limited 2015
04 Medical helium Medical Gas Data Sheet Medical helium Medical Gas Data Sheet 05

6.4 Special precautions Medical Helium cylinders should be: Leaks

for storage • stored under cover, preferably inside, kept dry and clean, and not subjected to extremes of heat or cold Having connected the regulator or manifold yoke to the cylinder check the connections for leaks using the
and away from stocks of combustible material following procedure:
• stored separately from industrial and other non-medical cylinders • Should leaks occur this will usually be evident by a hissing noise
• stored to maintain separation between full and empty cylinders • Should a leak occur between the valve outlet and the regulator or manifold yoke, depressurise and
• used in strict rotation so that cylinders with the earliest filling date are used first remove the fitting and fit an approved sealing washer. Reconnect the fitting to the valve with moderate
• stored separately from other medical cylinders within the store force only, fitting a replacement regulator or manifold tailpipe as required
• F size cylinders and larger should be stored vertically. • Sealing or jointing compounds must never be used to cure a leak
• Never use excessive force when connecting equipment to cylinders.
Warning notices prohibiting smoking and naked lights must be posted clearly in the cylinder storage area
and the Emergency Services should be advised of the location of the cylinder store. Use of cylinders
When Medical Helium cylinders are in use ensure that they are:
Care is needed when handling and using Medical Helium cylinders. • only used for medicinal purposes
• turned off, when not in use, using only moderate force to close the valve
6.5 Nature and contents of A summary of Medical Helium cylinders, their size, capacity and construction, type of valve fitted and valve • only moved with the appropriate size and type of trolley or handling device
container outlet pressure is detailed below: • handled with care and not knocked violently or allowed to fall
• firmly secured to a suitable cylinder support when in use
Cylinder Size Water capacity Gas content Valve Outlet Connection Cylinder Pressure • not used in the vicinity of persons smoking or near naked lights.
(litres) (litres) bar(g)
F 9.3 1200 BS 341 No.3 137 After use
Top Outlet fitted with MPR device When Medical Helium cylinders are empty ensure that:
• the cylinder valve is closed using moderate force only and the pressure in the regulator or tailpipe
Cylinders released
Medical Helium Cylinder and Valve Details • the valve outlet cap, where fitted, is replaced
All cylinders used for the supply of Medical Helium are manufactured from steel with a design working • the empty cylinders are immediately returned to the empty cylinder store for return to BOC.
pressure of at least 137 bar (g). The body and shoulder of the cylinders are coloured brown.

Cylinder valves 7. Marketing authorisation BOC Gases Ireland Limited

All Medical Helium cylinders are fitted with valves with outlet connections that conform to BS 341 (5/8” BSP holder J F Kennedy Drive
F). The cylinder valves are constructed from high tensile brass with a steel spindle fitted with a Nylon 6.6 Bluebell
insert. Dublin 12

6.6 Instructions for Use/Handling Care is need in the handling and use of medical helium gas cylinders. Helium is considerable lighter than
air, non-toxic, inert and will not support life. At high concentrations it acts as an asphyxiant by displacement 8. Marketing authorisation PA 208/8/1
of air. Symptoms of asphyxiation include rapid and gasping respiration, rapid fatigue, nausea and vomiting number(s)
and cyanosis and may lead to loss of consciousness and death from anoxia. Helium should never be inhaled
except in approved mixtures with other gases and under authorised circumstances.
9. Date of first Date of first authorisation: 01/04/1980.
General authorisation/renewal of Date of last renewal: 01/04/2010.
All personnel handling Medical Helium gas cylinders should have adequate knowledge of the: the authorisation
• properties of the gas
• correct operating procedures for the cylinder
• precautions and actions to be taken in the event of an emergency. 10. Date of revision of November 2015.
the text
Preparation for Use
To prepare the cylinder for use:
• remove the tamper evident seal and the valve outlet protection cap. Ensure the cap is retained so that it 11. Dosimetry (if applicable) Not applicable.
can be refitted after use
• ensure that an appropriate regulator is selected for connection to the cylinder
• ensure the connecting face on the regulator is clean and the sealing washer fitted is in good condition 12. Instructions Not applicable.
• connect the regulator, using moderate force only and connect the tubing to the regulator / flowmeter for preparation of
outlet. Only the appropriate regulator should be used for the particular gas concerned radiopharmaceuticals
• open the cylinder valve slowly and check for any leaks. (if applicable)

Reproduction without permission is strictly prohibited Reproduction without permission is strictly prohibited
© BOC Limited 2015 © BOC Limited 2015
6 Medical helium Medical Gas Data Sheet Medical helium Medical Gas Data Sheet 7

Additional Safety Information 4. Accidental release

measures
If a large volume of Helium is released you should:
• Close cylinder valve.

If release continues evacuate the area and ensure that the affected area is adequately ventilated before
re-entry.

Self-contained breathing apparatus is required to be used if Helium is released into a confined area without
adequate ventilation.

5. Disposal considerations It is recommended that medical helium cylinders should not be vented after use – they should be returned
to BOC, where they will be vented before refilling in a safe environment.

If, for safety reasons, a cylinder is required to be vented whilst in use, the gas should be vented to
atmosphere in a well ventilated area.

Contact BOC if further guidance on venting cylinders is required.

1. Contact information BOC telephone number to be used in the event of an emergency
ROI 1890 355 255
6. Transport of cylinders When Helium cylinders are required to be transported, ensure that the cylinders are:
• located in a compartment separated from the driver
2. Hazards Classification labelling and packaging regulations • adequately restrained
Warning. • not leaking and have their valves closed.
Contains gas under pressure; may explode if heated (H280).
Protect from sunlight: store in a well-ventilated place (P410 + P403). The vehicle must be adequately ventilated. Ensure the driver is aware of the potential hazards of the load
and knows what to do in the event of an accident or an emergency.

It is advisable to provide the driver with written instructions that detail the actions to be taken in the event
Dangerous preperations directive of an accident or emergency.
Keep out of the reach of children (S2)..
COMPRESSED OXIDISING Cylinders should be removed from the vehicle as soon as possible.
GAS AGENT
2 5.1

Additional safety statements 7. Transport information UN number UN1046

• No smoking or naked flames near medical gas cylinders Material Class 2  Classification Code 1A
• Use no oil or grease Labels 2.2
• Keep away from extremes of heat and combustible material Hazard identification number 20
• Store cylinders under cover in a clean, dry and well ventilated area Emergency Action Code 2T
Transport category 3
Helium is supplied as a compressed gas in a high
pressure cylinder. Cylinders may explode if subjected to extremely high temperatures
(if involved in a fire).

3. Fire fighting measures If Helium cylinders are involved in a fire:

• if it is safe to move the cylinders,
-- close cylinder valve to stop flow of product
-- move cylinders away from source of heat
• if it is not safe to move the cylinder,
-- cool with water from a protected position.

All types of fire extinguishers may be used to extinguish fires involving Helium.

Fire fighters should use self-contained breathing apparatus when dealing with a fire in which Medical Helium
cylinders are involved.

Reproduction without permission is strictly prohibited Reproduction without permission is strictly prohibited
© BOC Limited 2015 © BOC Limited 2015
 HLC/602170_HEL/UKS/BAMC/0915

BOC Healthcare
Patient Service Centre, Blyry Business Park, Athlone, Westmeath, Republic of Ireland
Tel 09064 70910, Fax 09064 74993, Email [email protected], www.bochealthcare.ie
The stripe symbol and the letters BOC are registered trade marks of The BOC Group Limited. Both BOC Limited and The BOC Group Limited are
members of The Linde Group, the parent company of which is Linde AG. Reproduction without permission is strictly prohibited. © BOC Limited 2015