MEDICAL LIQUID OXYGEN SAPIO LIFE 99.5% V/V, MEDICAL CRYOGENIC GAS

2. What you need to know before starting to use Medicinal Liquid Oxygen Sapio Life

Do not use Medicinal Liquid Oxygen Sapio Life

With flammable materials, oxygen allows and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the pressure conditions of use of the gas.

However, the most significant risks of inflammation in the presence of oxygen are associated with combustible materials, especially those of a fatty nature (oils, lubricants), and organic materials (tissues, wood, paper, plastics) that can ignite when in contact with oxygen, either spontaneously or under the effect of a spark, flame, or ignition point, or under the effects of adiabatic compression.

Warnings and Precautions

Consult your doctor, pharmacist, or nurse before starting to use Medicinal Liquid Oxygen Sapio Life.

In certain severe cases of oxygen deficiency, after 6 hours of exposure to an oxygen concentration (FiO2) of 100%, or after 24 hours of exposure to an oxygen concentration (FiO2) above 70%, pulmonary or neurological toxicity may occur.

High concentrations should be used for the shortest possible time and controlled by analyzing the gases in the arterial blood, while measuring the inhaled oxygen concentration; it is advisable to use the lowest effective dose to maintain the PaO2 concentration at 50-60 mm Hg (i.e., 5.65-7.96 kPa) and, after 24 hours of exposure, to maintain, as far as possible, a FiO2 concentration below 45%.

Precautions for use

For infants who require a FiO2 concentration above 30%, the PaO2 concentration should be regularly monitored to prevent it from exceeding 100 mm Hg (i.e., 13.3 kPa) due to the risk of retinal alterations.

Hyperbaric oxygen therapy: to avoid the risk of injuries caused by high pressure, in body cavities that contain air and are in communication with the outside, compression and decompression should be slow.

Using Medicinal Liquid Oxygen Sapio Life with other medicines

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medicine.

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

Pregnancy and Breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor before using this medicine.

It has been widely used without any notable effects.

Driving and Using Machines

There is no data on the effect of Medicinal Liquid Oxygen Sapio Life on driving and using machines.

3. How to use Medicinal Liquid Oxygen Sapio Life

Follow your doctor's instructions for administering this medicine exactly. If you are unsure, consult your doctor or pharmacist again.

Your doctor will determine the correct dose of Medicinal Liquid Oxygen Sapio Life and administer it through a system suitable for your needs, ensuring the correct supply of oxygen.

If you think the effect of Medicinal Liquid Oxygen Sapio Life is too strong or weak, tell your doctor.

If you use more Medicinal Liquid Oxygen Sapio Life than you should

The inhaled oxygen concentration should be reduced, and symptomatic treatment is recommended.

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount inhaled.

4. Possible Side Effects

Like all medicines, Medicinal Liquid Oxygen Sapio Life can have side effects, although not everyone may experience them.

In chronic respiratory failure, in particular, there is a possibility of apnea.

Inhaling high concentrations of oxygen can cause small collapses in the lung.

Administering oxygen at high pressures can cause damage to the inner ear (which can lead to a risk of eardrum rupture), sinuses, lungs (which can lead to a risk of pneumothorax).

Seizures have been reported after administering oxygen with a concentration (FiO2) of 100% for more than 6 hours, especially with high-pressure administration.

Lung damage can occur after administering oxygen concentrations (FiO2) above 80%.

In newborns, especially premature babies, exposed to high concentrations of oxygen (FiO2 > 40%; PaO2 above 80 mm Hg, i.e., 10.64 kPa) or for an extended period (more than 10 days at a FiO2 concentration > 30%), there is a risk of retinopathy, which appears between 3 and 6 weeks after treatment, and can regress or cause retinal detachment, or even permanent blindness.

Patients undergoing high oxygen pressures in chambers may experience claustrophobia.

If you experience side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this package leaflet.

5. Storage of Medicinal Liquid Oxygen Sapio Life

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiration date stated on the package. The expiration date is the last day of the month indicated.

All rules for handling pressure vessels and the instructions for your particular equipment must be followed.

Regarding storage and transportation, the following must be taken into account:

The evaporators, fixed or mobile, must be installed outdoors, in a clean area, without flammable materials, reserved for the storage of medical gases, and locked.

Under no circumstances should fire be lit, or smoking or greasing be allowed. Vehicles should not be parked in the transfer area. The risks caused by over-oxygenation of the atmosphere or clothing should be monitored and controlled.

The evaporators and cryogenic containers, fixed or mobile, must be protected from shocks, especially the filling, emptying, and safety organs (thin metal sheets, valves, manometers), from heat sources or ignition, from temperatures above 50°C, and from combustible materials.

Mobile evaporators and cryogenic containers should never be laid down.

6. Package Contents and Additional Information

Composition of Medicinal Liquid Oxygen Sapio Life

The active principle is Oxygen, in a concentration above 99.5% v/v.

Appearance of the Product and Package Contents:

Medicinal Liquid Oxygen Sapio Life is an inhalation gas supplied in home containers, cryogenic bottles, or isocontainers of various volumes, containing medicinal oxygen in a liquid state, for subsequent transfer to portable containers for final administration to the patient in a gaseous state.

Home cryogenic container:

1.2 L, 0.6 L, 10 L, 20 L, 21 L, 30 L, 31 L, 36 L, 37 L, 41 L, 45 L, 46 L.

Cryogenic bottle:

230 L, 180 L.

Not all package sizes may be marketed.

Instructions for Use/Handling

It is essential to read the instructions for use of your equipment carefully.

Do not smoke.

Do not approach a flame.

Do not grease.

Primarily, never introduce this gas into a device that may contain combustible bodies, and especially fatty bodies; never clean with combustible products, and especially those with a greasy texture, as the devices contain this gas, nor the keys, gaskets, linings, closing devices, and valves.

• Check the correct condition of the devices before use.
• Do not apply greasy products (vaseline, ointments...) to the patients' faces.
• Handle the devices with clean, grease-free hands.
• Do not use aerosol generators (hair spray, deodorants...), solvents (alcohol, gasoline...)
• in the devices or near them.
• In case of leakage, close the valve or feeding circuit valve that presents a leak. Never use a bottle with a leak and check the proper functioning of the auxiliary system.
• Ventilate, if possible, the place of use in case of small premises
• (vehicles, homes).
• Perform any handling of liquid oxygen containers with clean, suitable gloves for this use and protective glasses.
• Never touch the cold or frozen parts of the devices.
• In case of cryogenic burns, rinse abundantly with water.
• Use oxygen-specific fittings.
• Mobile cryogenic containers and evaporators: during the use of the passage flexibles, never exceed the maximum service pressure; do not subject the flexible to a too small curvature radius; never leave the flexible on the floor; monitor the condition of the external sleeve; and never grease the flexible.
• If clothing becomes saturated with oxygen, move away from the liquid oxygen source and areas with inflammation risks. Also, remove the clothing.
• Do not use intermediate fittings to connect two devices that do not fit.
• Mobile cryogenic container and evaporator: open the valve or valve progressively.
• Provide safety devices against over-pressures in each liquid oxygen circuit where there is a risk of trapped liquid between two valves.
• Use flexible connection elements in wall outlets provided with oxygen-specific nozzles.

Marketing Authorization Holder

SAPIO LIFE, S.A.U.

Camino de lo Cortao, 28

San Sebastián de los Reyes

28709 Madrid

Manufacturer:

SAPIO LIFE, S.A.U.

Camino de lo Cortao, 28

San Sebastián de los Reyes

28709 Madrid

Or

S.E. de CARBUROS METÁLICOS, S.A.

Ctra. Sevilla-Malaga-Granada, Km. 9,6

Polígono Ind. La Red

41500 – Sevilla

Or

S.E. de CARBUROS METÁLICOS, S.A.

C/ Dr. Fleming, 29

Pol. Ind. Ca N'Estella

08635 – Sant Esteve de Ses Rovires (Barcelona)

Or

S.E. de CARBUROS METÁLICOS, S.A.

Polígono Industrial Can Rubiol

C/ Celleters, 142

07141 Marratxí

Or

S.E. de CARBUROS METÁLICOS, S.A.

Barrio Chaco, s/n

48480 – Arrigorriaga (Vizcaya)

Date of the Last Revision of this Package Leaflet:

August 2005

Detailed and updated information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/