Oxigeno Medicinal Liquido Esteve Teijin 99.5 % v/v medicinal oxygen for inhalation

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MEDICINAL OXYGEN GAS ESTEVE TEIJIN 99.5% v/v oxygen for inhalation

Oxygen

Read the entire leaflet carefully before you start using this medicine.

• Keep this leaflet as you may need to read it again.
• If you have any questions, ask your doctor or pharmacist.
• This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms as you, because it could harm them.
• If you consider any of the adverse effects you experience to be serious, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.

Leaflet contents:

• 1. What OXIGEN MEDICINAL is and what it is used for
• 2. Before using OXIGEN MEDICINAL
• 3. How to use OXIGEN MEDICINAL
• 4. Possible side effects
• 5. How to store OXIGEN MEDICINAL
• 6. Further information

1. What OXIGENO MEDICINAL is and what it is used for

Oxygen belongs to a group of medicines called medicinal gases. Oxygen therapy is indicated in the following cases:

• Correction of oxygen deficiency of various origins requiring the administration of oxygen at normal or increased pressure.
• Supplying anaesthesia and resuscitation respirators.
• Administration via nebuliser of inhaled medications.

2. Before using MEDICAL OXYGEN

Do not use MEDICAL OXYGEN

With flammable materials.

Oxygen supports and accelerates combustion. The incompatibility of materials with oxygen depends on the pressure conditions under which the gas is used. However, fire hazards are greater in the presence of oxygen, particularly those associated with combustible substances, especially greasy materials (lubricants, oils), and organic materials (plastics, wood, paper, fabrics), which may ignite upon contact with oxygen, either spontaneously or due to a spark, flame, or ignition source, or as a result of adiabatic compression.

Therefore, do not smoke or place the container near sources of heat.

Take special care with MEDICAL OXYGEN

• In severe cases of oxygen deficiency. After 6 hours of exposure to 100% oxygen concentration, or after 24 hours of exposure to oxygen concentrations above 70%, pulmonary or neurological toxicity may occur (see section “Possible adverse effects”).
• High concentrations should be used for the shortest possible time and monitored by arterial blood gas analysis, while simultaneously measuring the concentration of inhaled oxygen. It is advisable, in any case, to use the lowest dose capable of maintaining arterial partial pressure of oxygen (PaO2) at 50–60 mm Hg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, it is recommended, as far as possible, to maintain an oxygen concentration below 45%.

Precautions for use:

• In infants, due to the risk of developing retinal abnormalities (see section “Use in infants”).
• Hyperbaric oxygen therapy: to avoid risks of injury caused by high pressure in body cavities containing air and communicating with the outside, compression and decompression must be performed slowly.
• Liquid oxygen is at a very low temperature (approximately -183°C) and may cause frostbite if it comes into contact with the skin. In such cases, rinse thoroughly with water (see section “Instructions for use/handling”).

Use with other medicines Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

Oxygen toxicity may be increased by: corticosteroids, certain anticancer drugs, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione deficiency.

Use in infants

For infants requiring an oxygen concentration above 30%, arterial partial pressure of oxygen (PaO2) must be monitored regularly to ensure it does not exceed 100 mm Hg (i.e., 13.3 kPa) due to the risk of developing retinal abnormalities (see section “Possible adverse effects”).

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine. It has been widely used without any notable adverse effects.

Driving and use of machines

There are no data available on the effects of MEDICAL OXYGEN on driving and operating machinery.

3. How to use MEDICAL OXYGEN

Follow exactly the instructions for administration of MEDICAL OXYGEN provided by your physician. If you have any doubts, consult your doctor or pharmacist.

Your doctor will determine the correct dose of MEDICAL OXYGEN and will administer it using a system appropriate to your needs, ensuring the delivery of the correct amount of oxygen. If you feel that the effect of MEDICAL OXYGEN is too strong or too weak, inform your doctor.

If you use more MEDICAL OXYGEN than you should
The concentration of inhaled oxygen should be reduced, and symptomatic treatment is recommended.

If you stop treatment with MEDICAL OXYGEN
If you have any further questions about the use of this product, ask your doctor or pharmacist.

4. Possible adverse effects

Like all medicines, MEDICINAL OXYGEN may cause adverse effects, although not everybody will experience them.

In particular, in chronic respiratory insufficiency, there may be a risk of apnea (transient suspension of breathing).

Inhalation of high oxygen concentrations may cause minor lung collapse.

Administration of oxygen at high pressure may cause injuries to the inner ear (with possible risk of tympanic membrane rupture), sinuses, and lungs (with possible risk of pneumothorax).

Seizure episodes have been reported after administration of 100% oxygen concentration for more than 6 hours, particularly when administered under high pressure. Pulmonary injuries may occur following administration of oxygen concentrations exceeding 80%.

In newborns, especially if premature, exposure to high oxygen concentrations (FiO2 >40%; PaO2 greater than 80 mm Hg (i.e., 10.64 kPa)) or prolonged exposure (more than 10 days at FiO2 > 30%) carries a risk of retinopathy, appearing between 3 and 6 weeks after treatment, which may either regress or lead to retinal detachment or even permanent blindness.

Patients undergoing high-pressure oxygen therapy in chambers may experience episodes of claustrophobia.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not listed in this leaflet, inform your doctor or pharmacist.

5. STORAGE OF MEDICINAL OXYGEN

Keep out of the reach and sight of children.

Do not use MEDICINAL OXYGEN after the expiry date stated on the container.

All regulations concerning the handling of pressure vessels must be followed.

The following must be taken into account regarding storage and transport:

Storage of containers:

Containers must be stored in a well-ventilated or ventilated area, protected from weather conditions, clean, free from flammable materials, reserved exclusively for the storage of medical gases, and capable of being locked. Empty and full containers must be stored separately. Containers must be protected against impact or falling, as well as from sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions. They must be kept in an upright position with valves closed.

Storage of containers at user facilities and in home settings:

The container must be installed in a location that protects it from impact or falling (e.g., using a stand with securing chains), sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, adverse weather conditions, and heat sources that may cause gasification.

Excessive storage must be avoided.

Transport of containers:

Do not park vehicles in oxygen transfer areas.

Containers must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling and to ensure they remain in an upright position.

During transport in vehicles, containers must be securely grouped. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

6. Additional Information

Composition of MEDICINAL OXYGEN

The active substance is Oxygen 99.5% v/v.

Appearance of the product and contents of the container

The containers are portable cryogenic containers made of stainless steel with various capacities.

Home Cryogenic Container:

Stationary Unit 20 containing approximately 20 liters of oxygen
Stationary Unit 21 containing approximately 21 liters of oxygen
Stationary Unit 30 containing approximately 30 liters of oxygen
Stationary Unit 31 containing approximately 31 liters of oxygen
Stationary Unit 36 containing approximately 36 liters of oxygen
Stationary Unit 37 containing approximately 37 liters of oxygen
Stationary Unit 41 containing approximately 41 liters of oxygen
Stationary Unit 45 containing approximately 45 liters of oxygen
Stationary Unit 46 containing approximately 46 liters of oxygen
Stationary Unit 60 containing approximately 60 liters of oxygen

Instructions for use/handling

Do not smoke.
Do not bring near flames.
Do not grease.

For liquid oxygen specifically, additional product-specific characteristics must also be considered as precautions for its use and handling:

• Oxygen is a gas heavier than air, which may accumulate in low-lying areas after vaporization of the liquid, creating a hazardous atmosphere.
• At atmospheric pressure, oxygen is a liquid at very low temperature (approximately -183°C) and may cause frostbite if it comes into contact with the skin due to splashing or handling the liquid without appropriate protective equipment. In case of frostbite, rinse thoroughly with water.
• One liter of liquid oxygen releases 850 liters of gas upon vaporization and warming to room temperature. The expansion of liquid oxygen upon warming is 850 times its liquid volume; therefore, appropriate precautions must be taken against overpressure in closed volumes (equipment and installations) and against over-oxygenation of materials and the atmosphere in enclosed spaces.

Medicinal oxygen containers are reserved exclusively for therapeutic use.

To prevent any incidents, the following instructions must be strictly observed:

• Never introduce this gas into any apparatus suspected of containing combustible materials, especially those of a greasy nature.
• Never clean with flammable products, especially greasy substances, any apparatus containing this gas, including taps, seals, gaskets, closure devices, and valves.
• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosols (hairspray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.
• Avoid exposure to sources of heat (stoves, radiators, fireplaces, etc.) or prolonged solar heating.
• Ventilate the area of use if possible, especially in confined spaces (vehicles, homes).
• Check the equipment is in good condition before use.
• At the time of delivery by the manufacturer, verify that the container is equipped with an intact tamper-evident seal.
• Handle the equipment with clean, grease-free hands.
• For handling cryogenic containers, use the specified personal protective equipment (goggles or face shields, clean gloves designated for this purpose, appropriate clothing, etc.) and follow the instructions and precautions described for the operation.
• Group containers together and keep them in an upright position.
• Use connections or flexible connecting elements specifically designed for oxygen.
• Use only equipment specifically approved for this product and for the intended pressure and temperature conditions.
• Provide safety devices against overpressure in each section of the circuit where residual liquid oxygen may be trapped between two valves.
• Never touch cold or frozen parts of the equipment.
• Do not use intermediate connectors to connect two devices that do not fit together.
• Small cryogenic containers (Stationary Units) or their auxiliary equipment (portable units or backpacks) may be equipped with accessory components for use (humidifier bottle, flowmeter, mask or nasal cannula, etc.). These devices must be used according to the prescribed conditions (flow rates, dosages, etc.).
• Open valves slowly and close them when the product is not in use.
• Never force any part of the cryogenic container or attempt to repair defective valves; in case of problems, contact the supplier.
• Never use a container that leaks.
• If clothing becomes saturated with oxygen, move away from the liquid oxygen source and from areas with fire hazards. Remove the clothing immediately.
• In case of cryogenic burn (cold injury), rinse thoroughly with water.
• Prevent backflow of substances into the container. Prevent water from entering the container.
• Do not leave the equipment valve open when not in use.

Marketing Authorization Holder:

ESTEVE TEIJIN HEALTHCARE, S.L.
Paseo del Ferrocarril, 369, Castelldefels,
08860 – Barcelona, Spain

Manufacturer:

ESTEVE TEIJIN HEALTHCARE, S.L.
Av. Diagonal, 579, 8th Floor,
Barcelona, 08014, Spain

OR

MESSER IBERICA DE GASES, S.A.U.
Autovía Tarragona-Salou Km 3.8
Vilaseca (Tarragona), Spain

OR

S.E. DE CARBUROS METALICOS, S.A.
Barrio Chaco s/n, Arrigorriaga – Vizcaya, SPAIN

OR

S.E. DE CARBUROS METALICOS, S.A.
Pol. Ind. Ca N'Estella. Doctor Fleming, 29, San Esteve de Sesrovires,
Barcelona – SPAIN

This leaflet was approved in JANUARY 2011

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/