MEDICAL LIQUID OXYGEN OXIGEN SALUD 99.5% V/V MEDICINAL CRYOGENIC GAS

2. What you need to know before starting to use Medicinal Liquid Oxygen Oxigen Salud

Do not use Medicinal Liquid Oxygen Oxigen Salud:

With flammable materials.

Oxygen allows and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the conditions of pressure use of the gas. However, the most significant risks of inflammation in the presence of oxygen are those associated with combustible compounds, especially those of a fatty nature (lubricants, oils) and organic materials (plastic materials, wood, paper, fabrics) that can ignite when in contact with oxygen, either spontaneously or under the effect of a spark, flame, or point of ignition, or under the effects of adiabatic compression.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Medicinal Liquid Oxygen Oxigen Salud:

• In certain severe cases of oxygen deficiency. After 6 hours of exposure to a concentration of oxygen of 100%, or after 24 hours of exposure to a concentration of oxygen above 70%, pulmonary or neurological toxicity may appear.
• High concentrations should be used for the shortest possible time and controlled through analysis of gases in arterial blood, while measuring the concentration of inhaled oxygen; it is advisable to use, in any case, the lowest dose capable of maintaining the partial arterial pressure of oxygen (PaO2) at 50-60 mmHg (i.e., 5.65-7.96 kPa) and, after 24 hours of exposure, try to maintain, as far as possible, a concentration of oxygen below 45%.

Precautions for use

• For infants who need a concentration above 30%, the partial arterial pressure of oxygen (PaO2) should be regularly controlled so that it does not exceed 100 mmHg (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 that contain air and are in communication with the outside, compression and decompression should be slow.

Using Medicinal Liquid Oxygen Oxigen Salud with other medications

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

The toxicity of oxygen can 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

Consult your doctor or pharmacist before using any medication.

It has been widely used without any notable effects.

Driving and using machines

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

3. How to use Medicinal Liquid Oxygen Oxigen Salud

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

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

If you think the effect of Medicinal Liquid Oxygen Oxigen Salud is too strong or too weak, inform your doctor.

If you use more Medicinal Liquid Oxygen than you should

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

In case of overdose, the concentration of inhaled oxygen should be reduced, and symptomatic treatment is recommended.

If you interrupt treatment with Medicinal Liquid Oxygen Oxigen Salud

If you have any other doubts about the use of this medication, ask your doctor or pharmacist.

4. Possible side effects

Like all medications, Medicinal Liquid Oxygen Oxigen Salud can cause side effects, although not everyone will 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 injuries to the inner ear (which can pose a risk of rupture of the eardrum), sinuses, lungs (which can pose a risk of pneumothorax).

Convulsive crises have been reported after administration of oxygen with a concentration of 100% for more than 6 hours, particularly with administration at high pressure.

Lung injuries can occur after administration of oxygen concentrations above 80%.

In newborns, especially if premature, exposed to high concentrations of oxygen (FiO2 > 40%; PaO2 above 80 mmHg, i.e., 10.64 kPa) or for a prolonged 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, may experience regression, or may cause retinal detachment, or even permanent blindness.

Patients undergoing high oxygen pressures in chambers may experience claustrophobia crises.

Reporting of side effects

If you experience any of the side effects, consult your doctor or pharmacist, even if they are not listed in this leaflet. You can also report them directly through the Spanish Medication Surveillance System for Human Use: www.notificaRAM.es

By reporting side effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Medicinal Liquid Oxygen Oxigen Salud

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

Do not use Medicinal Liquid Oxygen Oxigen Salud after the expiration date shown on the packaging.

All regulations regarding the handling of pressure vessels and the instructions of 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, nor should smoking or greasing be allowed. Nor should vehicles 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 cryogenic containers and evaporators should never be laid down.

6. Package contents and additional information

Composition of Medicinal Liquid Oxygen Oxigen Salud

• The active principle is Oxygen 99.5% v/v

Appearance of the product and package contents

Medicinal Liquid Oxygen Oxigen Salud is supplied in mobile cryogenic containers (for home, hospital, and transport use) and fixed cryogenic containers (tanks) of various volumes, which contain medicinal oxygen in a liquid state, for subsequent transfer to portable containers for final administration to the patient in a gaseous state.

Mobile cryogenic containers: 0.6 L, 1.2 L, 10 L, 20 L, 21 L, 30 L, 31 L, 36 L, 37 L, 41 L, 45 L, 46 L, 60 L, 180 L, 230 L, 450 L, 600 L, 1000 L, 7000 L, 8000 L, 10,000 L, 12,000 L, 17,000 L, 18,000 L, 20,000 L, 21,000 L, 22,000 L, 23,000 L, 24,000 L.

Fixed cryogenic container: 6000 L.

Not all package sizes may be marketed.

Marketing authorization holder

OXIGEN SALUD, S.A.

Carretera de Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona) Spain

Manufacturer

OXIGEN SALUD, S.A.

Carretera de Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona) Spain

Or

OXIGEN SALUD, S.A.

Polígono Industrial, Calle A, Parcela 63.

09320 Madrigal del Monte (Burgos) Spain

Or

OXIGEN SALUD, S.A.

Polígono Industrial del Celrà

C/Pujols, S/N

1. Celrà. Girona

Spain

Or

OXIGEN SALUD, S.A.

Poligono Industrial Campollano, Calle B, nº 2

02007 Albacete

Spain

Date of the last revision of the leaflet:August 2005

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

This information is intended only for healthcare professionals

Instructions for use/manipulation

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, since the devices contain this gas, nor the keys, joints, linings, closure devices, and valves.

The cryogenic containers of medicinal oxygen are exclusively reserved for therapeutic use.

To avoid any incidents, it is necessary to strictly follow the following guidelines:

• Check the correct condition of the devices before use.
• Do not grease the patients' faces with greasy products (vaseline, ointments…).
• Handle the devices with clean and grease-free hands.
• Do not use aerosol generators (lacquer, deodorants…), solvents (alcohol, gasoline…) in the devices or near them.
• In case of leakage, close the valve or feeding valve of the circuit that presents a leak. Never use a container that has 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 manipulation 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 specific fittings for oxygen.
• Evaporators and mobile cryogenic containers: during the use of the passage flexibles, never exceed the maximum service pressure; do not subject the flexible to a radius of curvature that is too small; never leave the flexible on the floor; monitor the condition of the outer sleeve; and never grease the flexible.
• If clothing becomes saturated with oxygen, move away from the source of liquid oxygen and from places that present risks of inflammation. Also, remove such clothing.
• Do not use intermediate fittings to connect two devices that do not fit.
• Evaporator and mobile cryogenic container: open the valve or valve progressively.
• Provide safety devices against over-pressures in each liquid oxygen circuit where there is a risk of liquid being trapped between two valves.

Use flexible connection elements in wall outlets, equipped with specific nozzles for oxygen.