Leaflet: information for the user

Oxygen Medical Liquid Oxigen Salud 99.5% v/v medicinal cryogenic gas

Read this leaflet carefully before starting to use this medicine, as it contains important information for you

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms as you, as it may harm them.
• If you experience any side effects, consult your doctor, pharmacist, or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Oxygen Medical Liquid Oxigen Salud and how is it used

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

3. How to use Oxygen Medical Liquid Oxigen Salud

4. Possible side effects

5. Storage of Oxygen Medical Liquid Oxigen Salud

6. Contents of the container 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 – resuscitation.
• Administration of inhalation medications via nebulizer.

Nouse Liquid Medical Oxygen Oxigen Salud:

With flammable materials.

Oxygen permits 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, highlighting those associated with combustible compounds, especially those of fatty nature (lubricants, oils) and to organic materials (plastic materials, wood, paper, textiles) 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 or pharmacist before starting to use Liquid Medical 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 greater than 70%, pulmonary or neurological toxicity may appear.
• High concentrations should be used for the shortest possible time and controlled by analyzing the gases in arterial blood, at the same time as measuring the concentration of inhaled oxygen; it is advisable to use in any case the smallest dose capable of maintaining the partial pressure of arterial 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, an oxygen concentration below 45%.

Precautions for use

• For infants who require a concentration greater than 30%, the partial pressure of arterial oxygen (PaO2) should be regularly controlled to prevent it from exceeding 100 mmHg (i.e., 13.3 kPa) due to the risk of appearance of retinal alterations.
• Hyperbaric oxygen therapy: in order to avoid risks of injuries caused by the high pressure, in the body cavities that contain air and are in communication with the outside, compression and decompression should be slow.

Use of Liquid Medical Oxygen Oxigen Salud with other medications

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

The toxicity of oxygen 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

Consult your doctor or pharmacist before using any medication.

It has been widely used without any notable effect.

Driving and use of machines

There are no data on the action of Liquid Medical Oxygen Oxigen Salud on driving and the use of 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 Oxigen Salud and administer it through an appropriate system that will ensure the correct supply of oxygen according to your needs.

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

If you use more Liquid Medical Oxygen than you should

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.

In case of overdose, reduce the concentration of oxygen inhaled and symptomatic treatment is recommended.

If you interrupt treatment with Liquid Medical Oxygen Oxigen Salud

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

Like all medications, Liquid Medical Oxygen Oxigen Salud can produce adverse effects, although not everyone may experience them.

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

Inhalation of high oxygen concentrations can cause small lung collapses.

Administration of oxygen at high pressures can cause inner ear damage (possibly posing a risk of tympanic membrane rupture), sinuses, lungs (possibly posing a risk of pneumothorax).

Seizures have been reported after administration of 100% oxygen for more than 6 hours, particularly with high-pressure administration.

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

In newborns, particularly premature infants, exposed to high oxygen concentrations (FiO2>40%; PaO2 greater than 80 mmHg, i.e., 10.64 kPa) or for an extended period (more than 10 days at a FiO2>30%), there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, and may experience regression or cause retinal detachment, or even permanent blindness.

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

Reporting Adverse Effects

If you experience any of these adverse effects, consult your doctor or pharmacist, even if they are not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:www.notificaRAM.es

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

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

Do not use Liquid Oxygen Medical Oxygen Health after the expiration date that appears on the packaging.

All guidelines related to the handling of pressure vessels and the instructions for 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 locked.

Under no circumstances should a fire be lit, smoke, or lubricate. Also, do not park 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 Oxygen Health

- The active ingredient is Oxygen 99.5% v/v

Appearance of the product and contents of the packaging

Medical Oxygen Liquid Oxygen Health is supplied in cryogenic mobile containers (for home, hospital, and transportation use) and fixed cryogenic containers (Deposits) of different volumes, containing medical oxygen in liquid state, for subsequent transfer to portable containers for final administration to the patient in gaseous state.

Cryogenic mobile 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, 10000 L, 12000 L, 17000 L, 18000 L, 20000 L, 21000 L, 22000 L, 23000 L, 24000 L.

Cryogenic fixed container: 6000 L.

Not all packaging sizes may be commercially available.

Holder of the marketing authorization

OXIGEN SALUD, S.A.

Carretera de Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)Spain

Responsible for manufacturing

OXIGEN SALUD, S.A.

Carretera de Rubí 141-143

08174 Sant Cugat del Vallès (Barcelona)

Spain

Ó

OXIGEN SALUD, S.A.

Polígono Industrial, Calle A, Parcela 63.

09320 Madrigal del Monte (Burgos)

Spain

Ó

OXIGEN SALUD, S.A.

Polígono Industrial del Celrà

C/Pujols, S/N

17460. Celrà.Gerona

Spain

Ó

OXIGEN SALUD, S.A.

Poligono Industrial Campollano, Calle B, nº 2

02007 Albacete

Spain

Last review date of the 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/

This information is intended solely for healthcare professionals

Instructions for use/manipulation

Do not smoke.

Do not bring near a flame.

Do not grease.

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

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

To avoid any incidents, it is necessary to respect the following instructions:

• Check the correct state of the apparatus before use.
• Do not apply greasy products (vaseline, ointments…) to the faces of patients.
• Manipulate 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. Never use a container that presents a leak 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 racors for oxygen.
• Evaporators and cryogenic 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 external cover; and do not grease 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.
• Evaporator and cryogenic mobile 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.