Medine.co.uk

Out of date information, search another

Medical Oxygen

Out of date information, search another
Informations for option: Medical Oxygen, show other option
Document: document 5 change

SUMMARY OF PRODUCT CHARACTERISTICS

1    NAME OF THE MEDICINAL PRODUCT

Medical Oxygen.

2    QUALITATIVE AND QUANTITATIVE COMPOSITION

Oxygen Ph. Eur. 100%.

3    PHARMACEUTICAL FORM

Inhalation gas.

4 CLINICAL PARTICULARS

4.1 Therapeutic indications

Hypoxia of any cause. As diluent for gaseous and volatile anaesthetic agents.

4.2 Posology and method of administration Use in adults and children

For respiratory use at concentrations of greater than 21%.

Use in neonates

When administering oxygen to neonates the inspired concentration of oxygen should not exceed 40%. (See 4.8).

Use in the elderly

When giving oxygen to elderly chronic bronchitic patients the inspired concentration of oxygen should only be raised by 1% increments and should not exceed 30%.

Instructions for use and handling of Medical Oxygen equipment

1. Cylinder valves should be opened momentarily prior to use to blow any foreign matter out of the outlet.

2.    Ensure that the connecting face on the yoke, manifold or regulator is clean and the sealing washer or ‘O’ ring where fitted is in good condition.

3.    Cylinder valves must be opened slowly.

4.    Only the appropriate regulator should be used for the particular gas concerned.

5.    Pipelines for medical gases should be installed in accordance with the conditions set out in HTM 02.

6.    Cylinder valves and any associated equipment must never be lubricated and must be kept free from oil and grease.

Leaks

1.    Should leaks occur this will usually be evident by a hissing noise.

2.    Leaks can be found by brushing the suspected area with an approved leak test solution.

3.    There are no user serviceable parts associated with these valves, do not attempt to correct any problems with leakage from any part of the valve itself. Label any faulty containers, and return them to Air Liquide for repair.

4.    Sealing or jointing compounds must never be used to cure a leak.

5.    Never use excessive force when connecting equipment to cylinders.

Use of Medical Oxygen cylinders

1.    Cylinders should be handled with care and not knocked violently or allowed to fall.

2.    Cylinders should only be moved with the appropriate size and type of trolley.

3.    When in use cylinders should be firmly secured to a suitable cylinder support.

4.    Cylinders containing liquifiable gas must always be used vertically with the valve uppermost.

5.    Medical gases must only be used for medicinal purposes.

6.    Smoking and naked lights must not be allowed within the vicinity of cylinders or pipeline outlets.

7.    After use cylinder valves should be closed using moderate force only and the pressure in the regulator or tailpipe released.

8.    When only a small amount of gas remains in a cylinder, the cylinder valve must be closed. It is important to leave a small residual pressure in each cylinder after use, in order to protect the inside of the cylinder from contamination.

4.3 Contraindications

None.

4.4 Special warnings and precautions for use

Oxygen supports combustion and smoking should be prohibited when oxygen is in use and no naked flame should be allowed.

4.5 Interaction with other medicinal products and other forms of interaction

None.

4.6 Pregnancy and lactation

Oxygen does not adversely affect pregnancy and lactation.

4.7 Effects on ability to drive and use machines

None.

4.8 Undesirable effects

Patients may experience retrosternal soreness associated with coughing and breathing difficulties after breathing pure oxygen at atmospheric pressure for several hours. This retrosternal soreness is exacerbated by smoking and exposure to cold air.

Convulsions and other central nervous system (CNS) effects may occur at two atmospheres or more, after a few hours exposure to pure oxygen. At higher pressures more rapid onset of CNS symptoms will occur.

Retrolental fibroplasia may occur in premature infants exposed to oxygen at concentrations greater than 40%.

4.9 Overdose

At two or more atmospheres pressure users may experience central nervous system toxicity including dizziness, convulsions and loss of consciousness after only 2-3 hours of exposure to pure oxygen.

Oxygen intake should be reduced or preferably stopped for a period of time and the effects will be reversed. Oxygen therapy can be restarted if desired.

5 PHARMACOLOGICAL PROPERTIES

5.1 Pharmacodynamic properties

Oxygen is a colourless, odourless gas with molecular weight 32, a boiling point of -183.1oC (at 1 bar) and a density of 1.355 kg/m3 (at 15oC and 1013mb).

Oxygen is present in the atmosphere at 21% and is an absolute necessity for life.

5.2 Pharmacokinetic properties

The uptake from the lungs is rapid because blood flow through the capillaries, where exchange takes place, occurs in about 0.5 seconds. The uptake of oxygen is favoured by the simultaneous loss of carbon dioxide which is then excreted in the expired air. Conversely the entry of carbon dioxide into the blood from the tissues facilitates oxygen transfer to the cells.

5.3 Preclinical safety data

There are no additional data of relevance to the prescriber.

6 PHARMACEUTICAL PARTICULARS

6.1 List of excipients

None.

6.2 Incompatibilities

There are no incompatibilities with oxygen in clinical practice.

6.3 Shelf life

Five years.

6.4 Special precautions for storage

Cylinders should be kept out of the reach of children.

Oxygen is non-flammable but strongly supports combustion (including some materials which do not normally burn in air). It is highly dangerous when in contact with oils, greases, tarry substances and many plastics due to the risk of spontaneous combustion with high pressure gases.

The normal precautions required in the storage of medical gas cylinders as described below are applicable.

•    Cylinders should be stored under cover, preferably inside, kept dry and clean and not subjected to extremes of heat or cold.

•    Cylinders should not be stored near stocks of combustible materials or near sources of heat.

•    Warning notices prohibiting smoking and naked lights must be posted clearly.

•    Emergency services should be advised of the location of the cylinder store.

•    Medical cylinders containing different gases should be segregated and identified within the store.

•    Full and used cylinders should be stored separately. Full cylinders should be used in strict rotation.

•    Cylinders must not be repainted, have any markings obscured or labels removed.

•    F size cylinders and larger should be stored vertically E size cylinders and smaller should be stored horizontally.

Precautions should be taken to protect cylinders from theft.

Oxygen is supplied in a gas cylinder, with valve, suitable for the pressure required for the product.

The types of cylinders normally used are specified in the following table.

Cylinder

Size

Water

Volume

(litres)

Fill

Pressure

(bar)

Fill

Volume

(m3)

Valve Type (1)

CC

1.0

300

0.30

4 bar outlet, Schraeder connector plus flow control

C

1.2

137

0.17

Pin-index

PD

2.0

137

0.30

Bullnose 5/8” BSP female, top outlet

PD4C

2.0

200

0.43

4 bar outlet, Schraeder connector plus flow control

AD 200

2.0

200

0.43

4 bar outlet, Schraeder connector plus flow control

AD

2.0

230

0.49

4 bar outlet, Schraeder connector plus flow control

CD 230

2.0

230

0.46

4 bar outlet, Schraeder connector plus flow control

CD 300

2.0

300

0.60

4 bar outlet, Schraeder connector plus flow control

D

2.32

137

0.34

Pin-index

DI

2.32

230

0.565

4 bar outlet, Schraeder connector plus flow control

E

4.68

137

0.68

Pin-index

AE

5.0

137

0.74

Pin-index

AE 200

5.0

200

1.10

Pin-index

F

9.43

137

1.36

Bullnose 5/8” BSP female, top outlet

F4 200

9.43

200

2.00

4 bar outlet, Schraeder connector

F4 230

9.43

230

2.30

4 bar outlet, Schraeder connector

F4C

9.43

230

2.30

4 bar outlet, Schraeder connector plus flow control

AF

10.0

137

1.44

Bullnose 5/8” BSP female, top outlet

Cylinder

Size

Water

Volume

(litres)

Fill

Pressure

(bar)

Fill

Volume

(m3)

Valve Type (1)

AF4

10.0

200

2.10

4 bar outlet, Schraeder connector

AF4C

10.00

200

2.10

4 bar outlet, Schraeder connector plus flow control

G

23.6

137

3.40

Bullnose 5/8” BSP female, top outlet

G4C 200

23.6

200

5.10

4 bar outlet, Schraeder connector plus flow control

G4

23.6

230

5.70

4 bar outlet, Schraeder connector

G4C

23.6

230

5.70

4 bar outlet, Schraeder connector plus flow control

SJ

50

137

7.30

Pin-index

J

50

200

10.60

Pin-index, pressure reducing 137 bar outlet

J200

50

200

10.60

Pin-index

50x14

Bank

700

200

147.00

Pin-index, pressure reducing 137 bar outlet

HC01

1.0

230

0.23

4 bar outlet, Schraeder connector

HC02

2.0

230

0.49

4 bar outlet, flow control

HCF

9.43

230

2.30

4 bar outlet, flow control

HC104C

10.0

200

2.1

4 bar outlet, Schraeder connector plus flow control

HC10

10.0

230

2.42

4 bar outlet, flow control

M02HQ

2.0

200

0.43

4 bar outlet, quick connect plus flow control

M02H

2.0

200

0.43

4 bar outlet, flow control

M02M

2.0

200

0.43

4 bar outlet, flow control

M02HQL

2.0

200

0.43

4 bar outlet, quick connect plus flow control

M02HL

2.0

200

0.43

4 bar outlet, flow control

M02ML

2.0

200

0.43

4 bar outlet, flow control

HC02HQ

2.0

230

0.49

4 bar outlet, quick connect plus flow control

HC02H

2.0

230

0.49

4 bar outlet, flow control

HC02M

2.0

230

0.49

4 bar outlet, flow control

HC10HQ

10

200

2.1

4 bar outlet, quick connect plus flow control

HC10H

10

200

2.1

4 bar outlet, flow control

HC10M

10

200

2.1

4 bar outlet, flow control

Cylinder

Size

Water

Volume

(litres)

Fill

Pressure

(bar)

Fill

Volume

(m3)

Valve Type (1)

HC10THQ

10

200

2.1

4 bar outlet, quick connect plus flow control

HC10TH

10

200

2.1

4 bar outlet, flow control

M11HQ

11

200

2.3

4 bar outlet, quick connect plus flow control

M11H

11

200

2.3

4 bar outlet, flow control

M11M

11

200

2.3

4 bar outlet, flow control

M11THQ

11

200

2.3

4 bar outlet, quick connect plus flow control

M11TH

11

200

2.3

4 bar outlet, flow control

M11HQL

11

200

2.3

4 bar outlet, quick connect plus flow control

M11HL

11

200

2.3

4 bar outlet, flow control

M11ML

11

200

2.3

4 bar outlet, flow control

M11THQL

11

200

2.3

4 bar outlet, quick connect plus flow control

M11THL

11

200

2.3

4 bar outlet, flow control

LW01UHQ

1.0

230

0.24

4 bar outlet, quick connect plus flow control

PD215S

1.0

200

0.24

4 bar outlet, quick connect plus flow control

LW01.1Q

1.1

230

0.26

4 bar outlet, quick connect plus flow control

PD215L

1.1

200

0.26

4 bar outlet, quick connect plus flow control

PD300

2.0

137

0.3

Bullnose 5/8” BSP female, top outlet

PD430G

2.0

200

0.43

4 bar outlet, flow control

PD490GQ

2.0

230

0.49

4 bar outlet, quick connect plus flow control

PD430C

2.0

200

0.43

4 bar outlet, flow control

LW02HQ

2.0

230

0.49

4 bar outlet, quick connect plus flow control

CB430Q

2.0

200

0.43

4 bar outlet, quick connect plus flow control

LW02H

2.0

230

0.49

4 bar outlet, flow control

LW02UHQ

2.0

230

0.49

4 bar outlet, quick connect plus flow control

MGS430

2.0

200

0.43

4 bar outlet, quick connect plus flow control

AF1360

9.4

137

1.36

Bullnose 5/8” BSP female, top outlet

HC10BU

10.0

137

1.36

4 bar outlet, flow control

IF2150

10.0

200

2.15

4 bar outlet, flow control

DF

2.0

137

0.34

Pin-index

DF200

2.0

200

0.43

Pin index

Cylinder

Size

Water

Volume

(litres)

Fill

Pressure

(bar)

Fill

Volume

(m3)

Valve Type (1)

APD

2.0

137

0.34

Bullnose 5/8” BSP female, top outlet

APD200

2.0

200

0.43

Bullnose 5/8” BSP female, top outlet

APD300

2.0

300

0.49

Bullnose 5/8” BSP female, top outlet

AD 300

2.0

300

0.64

4 bar outlet, quick connect plus flow control

Takeo 5L

5.0

200

1.08

4 bar outlet, quick connect plus flow control

Takeo 5L 230

5.0

230

1.24

4 bar outlet, quick connect plus flow control

AB10

10

137

1.44

Bullnose 5/8” BSP female, top outlet

AB104C

10

200

2.1

4 bar outlet, quick connect plus flow control

AB104C

230

10

230

2.42

4 bar outlet, quick connect plus flow control

B10

10

137

1.44

Bullnose 5/8” BSP female, top outlet

B104C

10

200

2.1

4 bar outlet, quick connect plus flow control

B104C 230

10

230

2.42

4 bar outlet, quick connect plus flow control

HC02BU

2

200

0.49

4 bar outlet, quick connect plus flow control

HC09BU

9.4

137

1.36

4 bar outlet, quick connect plus flow control

Takeo 2L

2

200

0.43

4 bar outlet, quick connect plus flow control

Takeo 2L 230

2

230

0.49

4 bar outlet, quick connect plus flow control

Takeo 11L

11

200

2.3

4 bar outlet, quick connect plus flow control

Note: (1) Cylinder valves conform to BS341 (non pin-index - except the 4bar outlet valves which are proprietary) and BS EN ISO 407 (pin-index)

(2) N.B. Cylinders with 200 bar pressure at the outlet, and should only be used on a manifold installed to HTM 02, or with a 200 bar regulator.

The colour of Medical Oxygen cylinders in the UK is in a period of change.

The colour coding of the shoulder of Medical Oxygen is white. The body of the cylinder will be either black or white.

The aim is to complete a period of change over from the black body to the white bodied cylinder. The shoulder colour of the cylinder will remain as white. This period of change will be completed by January 1st 2026.

Not all pack sizes may be marketed

6.6 Special precautions for disposal

Cylinders that are no longer required should be returned to Air Liquide.

See section 4.2 for ‘Instructions for use and handling of Medical Oxygen equipment’.

7    MARKETING AUTHORISATION HOLDER

Air Liquide Ltd Station Road Coleshill Birmingham West Midlands B46 1JY

8    MARKETING AUTHORISATION NUMBER(S)

PL 15929/0005

9    DATE OF FIRST AUTHORISATION/RENEWAL OF THE

AUTHORISATION

4th February 1998 / 17th April 2003

10 DATE OF REVISION OF THE TEXT

10/04/2014