HIGHLIGHTS OF PRESCRIBING INFORMATION Hypersensitivity to sumatriptan (angioedema and anaphylaxis These highlights do not include all the information needed to use ZEMBRACE™ SymTouch™ safely and effectively. See full prescribing Severe hepatic impairment information for ZEMBRACE™ SymTouch™. WARNINGS AND PRECAUTIONS
→ Medical Gas Data Sheet (MGDS) Medical Gas Data Sheet (MGDS) 9% helium/35% oxygen/ nitrogen medical gas mixture Essential safety information BOC: Living healthcare 9% helium/35% oxygen/nitrogen medical gas mixture SPC 9% helium/35% oxygen/nitrogen medical 1. Name of the 9% helium/35% oxygen/nitrogen medical gas mixture.
medicinal product 2. Qualitative and 9% helium/35% oxygen/nitrogen medical gas mixture is a medicinal gas mixture quantitative composition of helium, oxygen and nitrogen.
The mixture specification is as fol ows: Maximum impurity levels: carbon monoxide: 5vpm carbon dioxide: 300vpm The medical oxygen specification complies with the current European Pharmacopoeia monograph (0417). The nitrogen specification complies with the current European Pharmacopoeia monograph (1247). The helium specification complies with the current European Pharmacopoeia monograph (2155).
3. Pharmaceutical form Medicinal gas, compressed.
4. Clinical particulars 4.1 Therapeutic indications 9% helium/35% oxygen/nitrogen medical gas mixture is used for pulmonary physiology.
Indications for 9% helium/35% oxygen/nitrogen medical gas mixture are dictated by the clinical 4.2 Posology and method of 9% helium/35% oxygen/nitrogen medical gas mixture is administered through the lungs by inhalation usual y administration through volumetric metering and absorption analysis devices. It may be administered by means of a tent.
4.3 Contraindications There are no contraindications for the use of 9% helium/35% oxygen/nitrogen medical gas mixture in any The use and dosage of 9% helium/35% oxygen/nitrogen medical gas mixture is determined by the respiratory function test being applied.
9% helium/35% oxygen/nitrogen medical gas mixture should not normal y be used with elderly, chronic bronchitic patients as the oxygen concentration exceeds 35%.
Reproduction without permission is strictly prohibited BOC Limited 2012 9% helium/35% oxygen/nitrogen medical gas mixture SPCt 4.4 Special warnings and Where the patient has been exposed to agents which are toxic to the lungs, such as Paraquat, the use of precautions for use gases containing more than 21% oxygen should be avoided.
4.5 Interaction with other The use of higher levels of oxygen can increase the risk of pulmonary toxicity in patients who have medicinal products and other been administered Bleomycin, Amiodarone and Nitrofurantoin or similar antibiotics. In these cases 9% forms of interaction helium/35% oxygen/nitrogen medical gas mixture should be administered with caution and at levels kept as low as possible. 4.6 Pregnancy and lactation 9% helium/35% oxygen/nitrogen medical gas mixture is not contraindicated in pregnancy and is unlikely to 4.7 Effects on ability to drive and In normal circumstances, 9% helium/35% oxygen/nitrogen medical gas mixture does not affect ability to use machines drive or to operate machinery.
4.8 Undesirable effects High barometric pressures, above 3bar(g), may produce convulsions due to oxygen content, if continued for more than a few hours.
4.9 Overdose None applicable.
5. Pharmacological Pharmacotherapeutic group – medical gas.
properties ATC Code - Vø3AN.
5.1 Pharmacodynamic properties Helium - The characteristics of helium are: • odourless, colourless gas • molecular weight 4 • boiling point -269°C (at 1bar(g)) • density 0.169kg/m3 (at 15°C).
Helium has no physiological activity and will not support life.
Oxygen - The characteristics of oxygen are: • odourless, colourless gas • molecular weight 32 • boiling point -183.1°C (at 1bar(g)) • density 1.355kg/m3 (at 15°C).
Oxygen is present in the atmosphere at 21% and is an absolute necessity for life.
Nitrogen - The characteristics of nitrogen are: • odourless, colourless gas • molecular weight 28 • boiling point -196°C (at 1bar(g)) • density 1.185kg/m3 (at 15°C).
Nitrogen is a non-toxic inert gas. It has no physiological activity and will not support life.
5.2 Pharmacokinetic properties Helium has a low co-efficient of solubility and 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 mixture will flow through bronchi more easily than air. In patients with respiratory obstruction, therefore, more oxygen may be presented to the alveolus for the same ventilatory effort. The absorption of helium from alveoli is very slow. Inhalation of helium may be used to prevent atelectasis.
The uptake of oxygen by the blood in the lungs and discharge to the tissues is determined by the oxygen dissociation curve. The characteristic sigmoid shape ensures that, at tensions between 40 and 15mm Hg, the oxygen carried in the blood from the lungs can be readily given up to the tissues.
The uptake from the lungs is rapid because blood flow through the capil aries, 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 Reproduction without permission is strictly prohibited BOC Limited 2012 9% helium/35% oxygen/nitrogen medical gas mixture SPC tissues facilitates oxygen transfer to the cel s.
At rest, mixed venous blood returning to the lungs contains 13-14ml of oxygen per 100ml, but with severe exercise, the oxygen content may fall to 3-4ml. In very active tissue, almost complete extraction occurs. Nitrogen is soluble in fat but saturates slowly. Under pressure, nitrogen will form bubbles in tissues and 5.3 Preclinical safety data None stated.
6. Pharmaceutical 6.1 List of excipients None.
6.2 Incompatibilities The constituent gases of 9% helium/35% oxygen/nitrogen medical gas mixture are chemical y inactive and will not normal y react with other compounds at normal temperatures.
However, the medical oxygen component of 9% helium/35% oxygen/nitrogen medical gas mixture strongly supports combustion and will cause substances to burn, including some materials that will not normal y burn in air. It is highly dangerous in the presence of oils, greases, tarry substances and many plastics due to the risk of spontaneous combustion in the presence of medical oxygen in relatively high concentrations.
6.3 Shelf life 36 months.
6.4 Special precautions 9% helium/35% oxygen/nitrogen medical gas mixture cylinders should be: for storage • stored under cover, preferably inside, kept dry and clean, and not subjected to extremes of heat or cold and away from stocks of combustible material • stored separately from industrial and other non-medical cylinders • stored to maintain separation between full and empty cylinders • used in strict rotation so that cylinders with the earliest fil ing date are used first • stored separately from other medical cylinders within the store.
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.
Care is needed when handling and using 9% helium/35% oxygen/nitrogen medical gas mixture cylinders.
6.5 Nature and contents of 9% helium/35% oxygen/nitrogen medical gas mixture cylinder and valve details.
container All cylinders used for the storage of 9% helium/35% oxygen/nitrogen medical gas mixture are manufactured from aluminium with a designed working pressure of at least 150bar(g). These cylinders are designed to be used with a pressure regulator.
A summary of 9% helium/35% oxygen/nitrogen medical gas mixture cylinders, their size and construction, type of valve fitted and valve outlet connection is detailed below: Valve construction The cylinder valves are constructed from high tensile brass with a steel spindle fitted with a Nylon 6.6 insert.
Reproduction without permission is strictly prohibited BOC Limited 2012 9% helium/35% oxygen/nitrogen medical gas mixture SPC 6.6 Special precautions for All personnel handling 9% helium/35% oxygen/nitrogen medical gas mixture cylinders should have disposal and other handling adequate knowledge of • properties of the gas • correct operating procedures for the cylinder • precautions and actions to be taken in the event of an emergency.
Preparation for use To prepare the cylinder for use: • remove the tamper evident seal and the valve outlet protection cap. Ensure the cap, where fitted, is retained so that it can be refitted after use • do not remove and discard any batch labels fitted to the cylinder • 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 • ensure that the cylinder valves and any associated equipment is not lubricated and kept free from oil and • connect the regulator, using moderate force only and connect the tubing to the regulator/flowmeter outlet. Only the appropriate regulator should be used for the particular gas concerned • open the cylinder valve slowly and check for any leaks.
Leaks Having connected the regulator or manifold yoke to the cylinder, check the connections for leaks using the fol owing procedure: • should leaks occur this will usual y be evident by a hissing noise • should a leak occur between the valve outlet and the regulator or manifold yoke, depressurise and remove the fitting and fit an approved sealing washer. Reconnect the fitting to the valve with moderate force only, fitting a replacement regulator or manifold tailpipe as required • sealing or jointing compounds must never be used to cure a leak • if leak persists, label cylinder and return to BOC.
Use of cylinders When 9% helium/35%oxygen/nitrogen medical gas mixture cylinders are in use, ensure that they are: • only used for medicinal purposes • turned off, when not in use, using only moderate force to close the valve • only moved with the appropriate size and type of trol ey or handling device • handled with care and not knocked violently or al owed to fal • firmly secured to a suitable cylinder support when in use • not al owed to have any markings, labels or batch labels obscured or removed • not used in the vicinity of persons smoking or near naked lights.
After use When the 9% helium/35% oxygen/nitrogen medical gas mixture cylinders are empty, ensure that the: • cylinder valves are closed using moderate force only and the pressure in the regulator or tailpipe • valve outlet cap, where fitted, is replaced • empty cylinders are immediately returned to an empty cylinder storage area for return to BOC.3 7. Marketing authorisation BOC Ltd, The Priestley Centre, 10 Priestley Road, The Surrey Research Park, Guildford, Surrey GU2 7XY.
8. Marketing authorisation PL 00735/5015R.
9. Date of first Date first granted: 01/09/1972.
of the authorisation Date of renewal: 27/03/1996.
10. Date of revision of the 23/04/2013 11. Dosimetry (if applicable) Not applicable. 12. Instructions for preparation of Not applicable.
radiopharmaceuticals Reproduction without permission is strictly prohibited BOC Limited 2012 9% helium/35% oxygen/nitrogen medical gas mixture SPC Additional Safety Information 1. Contact information BOC telephone number to be used in the event of an emergency 2. Hazards Classification label ing and packaging regulations May cause or intensify fire; oxidiser (H270).
Contains gas under pressure; may explode if heated (H280).
Keep/Store away from clothing, hydrocarbons and combustible materials (P220).
Keep reduction valves free from grease and oil (P244).
In case of fire: stop leak if safe to do so (P370 + P376).
Protect from sunlight: store in a wel -ventilated place P410 + P403).
Dangerous Preparations Directive Contact with combustible material may cause fire (R8).
Keep out of the reach of children (S2).
Keep away from combustible material (S17).
• Contact with combustible material my cause fire • No smoking or naked flames near medical oxygen cylinders • Use no oil or grease • Keep away from extremes of heat and combustible material • Store cylinders under cover in a clean, dry and well ventilated area Medical oxygen 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).
Medical oxygen is a non-flammable gas but is a very strong oxidant. It will strongly support and It may react violently with combustible materials such as oils and grease.
3. Fire fighting measures If medical oxygen cylinders are involved in a fire: • if it is safe to move the cylinders, -close cylinder valve to stop the flow of product -move cylinders away from source of heat • if it is not safe to move the cylinders, -cool with water from a protected position.
All types of fire extinguishers may be used when dealing with a fire involving medical oxygen cylinders.
No special protective equipment for fire fighters is required. There are no hazardous combustion products released from the gas.
Reproduction without permission is strictly prohibited BOC Limited 2012 9% helium/35% oxygen/nitrogen medical gas mixture SPC 4. Accidental release If a large volume of medical oxygen is released, if safe to do so, you should: measures • close the cylinder valve • where possible, isolate all sources of ignition • if release continues, evacuate the area and ensure that the affected area is • adequately ventilated before re-entry.
Self-contained breathing apparatus is not required to be used if oxygen is released in a confined area.
5. Exposure controls When using medical oxygen cylinders ensure adequate ventilation. If clothing becomes impregnated with oxygen (due to a leak), keep away from sources of ignition or open flames. Clothing impregnated with oxygen should be ventilated in fresh air for a minimum of 15 minutes.
6. Disposal considerations It is recommended that medical oxygen cylinders should not be vented after use – they should be returned to BOC, with any residual gas, where they will be vented before refil ing in a safe environment.
If, for safety reasons, a cylinder is required to be vented after use, the gas should be vented to atmosphere in a well ventilated area.
Contact BOC if further guidance on venting cylinders is required.
7. Transport of cylinders When medical oxygen cylinders are required to be transported, ensure that the cylinders are: • located in a compartment separated from the driver • adequately restrained • not leaking and have their valves closed.
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 of an accident or emergency. Cylinders should be removed from the vehicle as soon as possible.
8. Use of cylinders in transit – If you need to use medical oxygen within a vehicle, you are advised to: advice to patient/carer • prohibit smoking in the vehicle • only carry the minimum number of cylinders to provide sufficient gas for patient use during the • ensure all cylinders are adequately restrained • keep cylinder valves closed when not in use • avoid using the cylinder when the vehicle is being refuel ed • set the ventilation system to fresh air or open a window to provide adequate ventilation and to prevent oxygen enrichment within the vehicle • avoid leaving cylinders unattended in a vehicle. Unless the vehicle is specifical y designed to carry medical oxygen cylinders,they should be removed from the vehicle overnight.
9. Transport information UN number UN1072 oxygen, compressed Hazard identification number Emergency Action Code Tunnel Restriction Code Transport category Reproduction without permission is strictly prohibited BOC Limited 2012 Customer Service Centre, Priestley Road, Worsley, Manchester M28 2UT Tel 0800 111 333, Fax 0800 111 555, [email protected], www.bochealthcare.co.uk 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 2012
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