Label: information for the user

Oxygen Medical Liquid Sapio Life 99.5% v/v medicinal cryogenic gas

Read this label carefully before starting to use this medication, as it contains important information for you.

• Keep this label, as you may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• This medication has been prescribed only to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are not listed in this label.

1. What is Oxygen Medical Liquid Sapio Life and how it is used

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

3. How to use Oxygen Medical Liquid Sapio Life

4. Possible adverse effects

5. Storage of Oxygen Medical Liquid Sapio Life

6. Contents of the package and additional information

Oxygen is an essential element for the body. Oxygen treatment is indicated in the following cases:

• Correction of oxygen deficiency from various sources requiring oxygen administration at normal or elevated pressure.
• Supplying oxygen to ventilators during anesthesia-reanimation.
• Administration of inhalation medications via nebulizer.

No use Oxígeno Medicinal Líquido Sapio Life

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

However, the most important risks of inflammation in the presence of oxygen are associated with combustible materials, especially those of fatty nature (oils, lubricants) and organic materials (tissues, wood, paper, plastic materials) that can ignite upon 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 Oxígeno Medicinal Líquido 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) greater than 70%, pulmonary or neurological toxicity may appear.

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

Precautions for use

For infants who require a FiO2 concentration greater than 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: in order to avoid risks of injuries caused by high pressure, in body cavities containing air and communicating with the outside, compression and decompression should be slow.

Use of Oxígeno Medicinal Líquido Sapio Life with other medications

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

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

Pregnancy and breastfeeding

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

It has been widely used without any notable effect.

Driving and operating machines

There are no data on the effect of Oxígeno Medicinal Líquido Sapio Life on driving and operating machines.

Follow exactly the administration instructions for this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist again.

Your doctor will determine the correct dose of Liquid Medical Oxygen Sapio Life and administer it through an appropriate system tailored to your needs, ensuring the correct supply of oxygen.

If you estimate that the action of Liquid Medical Oxygen Sapio Life is too strong or weak, inform your doctor.

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

Reduce the concentration of inhaled oxygen and symptomatic treatment is recommended.

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

Like all medications, Medical Liquid Oxygen Sapio Life may have adverse effects, although not everyone will experience them.

In particular, chronic respiratory insufficiency may lead to the possibility of apnea.

The inhalation of high oxygen concentrations may cause small lung collapses.

The administration of oxygen at high pressures may cause inner ear injuries (potentially posing a risk of tympanic membrane rupture), sinuses, lungs (potentially posing a risk of pneumothorax).

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

Pulmonary injuries may occur after administration of oxygen concentrations (FiO2) above 80%.

In newborns, particularly premature ones, exposed to strong oxygen concentrations (FiO2 >40%; PaO2 above 80 mm Hg, i.e., 10.64 kPa) or for an extended period (more than 10 days at a concentration FiO2 > 30%), there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, potentially experiencing regression or causing retinal detachment, or even permanent blindness.

Patients subjected to high oxygen pressures in chambers may experience claustrophobia crises.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

All guidelines related to the handling of pressure vessels and the instructions of your specific equipment must be followed.

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

Evaporators, fixed or mobile, must be installed outdoors, in a clean area, free from flammable materials, reserved for the storage of medical gases and closed with a key.

Under no circumstances should a fire be lit, smoke, or lubricate. Neither should vehicles be parked in the transfer area. The risks caused by over-oxygenation of the atmosphere or clothing must be monitored and controlled.

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 of 50°C and above, and from combustible materials.

Mobile evaporators and cryogenic containers must never be tipped over.

Composition of Medical Oxygen Liquid Sapio Life

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

Appearance of the product and contents of the packaging:

Medical Oxygen Liquid Sapio Life is a gas for inhalation that is supplied in domestic containers, bottles or cryogenic isocontainers of different volumes, containing medical oxygen in liquid state, for subsequent transfer to portable containers for final administration to the patient in gaseous state.

Domestic 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 packaging sizes may be commercially available.

Instructions foruse/ manipulation

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

Do not smoke.

Do not approach a flame

Do not lubricate.

Primarily, do not introduce this gas into an apparatus that may be suspected to contain combustible bodies and, in particular, fatty bodies; do not clean with combustible products and, in particular, with fatty substances, as the apparatus contain this gas, nor the keys, the joints, the linings, the closure devices and the valves.

• Check the correct state of the apparatus before use.
• Do not apply greasy products (vaseline, ointments...) to the faces of patients.
• Handle the apparatus with clean and grease-free hands.
• Do not use aerosol generators (lacquer, deodorants...), solvents (alcohol, gasoline...)
• in the apparatus or near them.
• In case of leakage, close the valve or the feeding valve of the circuit that presents a leak tightness failure. Do not use a bottle that presents a leak tightness defect and check the good functioning of the auxiliary system.
• Ventilate, if possible, the place of use in case of small rooms
• (vehicles, homes).
• Perform any manipulation on oxygen liquid containers with clean gloves suitable for this use and protective glasses.
• Never touch the cold or frozen parts of the apparatus.
• In case of cryogenic burn, abundantly rinse with water.
• Use specific oxygen racors.
• Cryogenic evaporators and mobile containers: during the use of the flexible connections, never exceed the maximum service pressure; do not subject the flexible to a too small curvature radius; do not leave the flexible on the floor; supervise the state of the outer casing; and do not lubricate the flexible.
• If the clothing becomes saturated with oxygen, move away from the oxygen liquid source and from areas that present a risk of inflammation. Remove this clothing as well.
• Do not use intermediate racors to connect two devices that do not fit.
• Cryogenic evaporator and container: open the valve or valve gradually.
• Provide safety devices against over-pressures in each oxygen liquid circuit where there is a risk of liquid being trapped between two valves.
• Use flexible connection elements in wall outlets provided with specific nozzles for oxygen.

Holder of the marketing authorization

SAPIO LIFE, S.A.U.

Camino de lo Cortao, 28

San Sebastián de los Reyes

28709 Madrid

Responsible for manufacturing:

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 review of this prospectus:

August 2005

The detailed and updated information of this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/