This page is for general information. Consult a doctor for personal advice. Call emergency services if symptoms are severe.

How to use MEDICAL OXYGEN SAPIO LIFE 99.5% v/v COMPRESSED MEDICAL GAS

Introduction

Package Leaflet: Information for the User

Medicinal Oxygen Gas Sapio Life99.5% v/v compressed medicinal gas

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

Keep this leaflet, you may need to read it again.
If you have any further questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any possible side effects not listed in this leaflet.

Contents of the package leaflet

What is Medicinal Oxygen Gas Sapio Life and what is it used for
What you need to know before you start using Medicinal Oxygen Gas Sapio Life
How to use Medicinal Oxygen Gas Sapio Life
Possible side effects
Storage of Medicinal Oxygen Gas Sapio Life
Contents of the pack and other information

1. What is Medicinal Oxygen Gas Sapio Life and what is it used for

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

Correction of oxygen deficiency of various origins that require the administration of oxygen at normal or high pressure.
Feeding of respirators in anesthesia - resuscitation.
Administration of medications for inhalation via a nebulizer.

2. What you need to know before you start using Medicinal Oxygen Gas Sapio Life

Do not use Medicinal Oxygen Gas Sapio Life:

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

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Medicinal Oxygen Gas 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 appear.

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

Precautions for use

For infants who need a FiO2 concentration above 30%, the PaO2 concentration should be regularly controlled so that it does not exceed 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 that contain air and are in communication with the outside, compression and decompression must be slow.

Use of Medicinal Oxygen Gas 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 Oxygen Gas Sapio Life on driving and using machines.

3. How to use Medicinal Oxygen Gas Sapio Life

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

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

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

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

The inhaled oxygen concentration should be decreased 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 Oxygen Gas Sapio Life can cause side effects, although not everybody gets 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 lead to a risk of rupture of the eardrum), sinuses, lungs (which can lead to a risk of pneumothorax).

Convulsions have been reported after administration of oxygen with a concentration (FiO2) of 100% for more than 6 hours, particularly with high-pressure administration. Pulmonary injuries can occur after administration of oxygen concentrations (FiO2) above 80%.

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

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

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

5. Storage of Medicinal Oxygen Gas Sapio Life

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

Do not use this medicine after the expiry date which is stated on the packaging. The expiry date is the last day of the month stated.

All rules related to the handling of pressure vessels must be followed.

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

Storage of cylinders:

Cylinders must be stored in a well-ventilated or ventilated area, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked.

Empty and full cylinders must be stored separately.

Cylinders must be protected from the risk of shocks or falls, as well as from heat sources or ignition, temperatures equal to or above 50°C, and also from combustible materials and weather conditions. Cylinders with a capacity greater than 5 L must be kept in a vertical position, with the valves closed.

Storage of cylinders in the user service and at home:

The cylinder must be installed in a location that allows it to be protected from the risks of shocks and falls (such as a support with chains), heat sources or ignition, temperatures equal to or above 50°C, combustible materials, and weather conditions.

Excessive storage should be avoided.

Transport of cylinders:

Cylinders must be transported with the help of suitable material (such as a cart with chains, barriers, or rings) to protect them from the risk of shocks or falls.

Special attention must also be paid to securing the reducer to avoid accidental breakage risks.

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

6. Contents of the pack and other information

Composition of Medicinal Oxygen Gas Sapio Life

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

Appearance and packaging of the product

It is packaged in cylinders at 200 bar pressure at 15°C. The cylinders can be made of steel, compact steel, aluminum, or compact aluminum with the following volumes: 0.75 L; 1 L; 1.4 L; 1.6 L; 2 L; 2.5 L; 2.75 L; 3 L; 3.5 L; 4 L; 4.55 L; 4.7 L; 5 L; 6.7 L; 7 L; 10 L; 10.7 L; 13 L; 13.4 L; 15 L; 20 L; 30 L; 40 L; 50 L in liters of water.

Not all pack sizes may be marketed

Instructions for use / handling

Do not smoke.

Do not approach a flame.

Do not grease.

In particular:

Never introduce this gas into a device that is suspected to contain combustible materials, especially if they are of a fatty nature;
Never clean the devices that contain this gas or the valves, gaskets, seals, closing devices, and valves with combustible products, especially if they are of a fatty nature;
Never apply any fatty material (vaseline, pomades...) to the face of patients;
Never use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or near it.

Medicinal oxygen cylinders are exclusively reserved for therapeutic use.

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

Check the good condition of the material before its use.
Group cylinders with a capacity greater than 5 liters with a suitable means (chains, hooks, ...) to keep them in a vertical position and avoid any accidental fall; do not use cylinders if their pressure is less than 10 bar.
Never force a cylinder into a support that is too narrow for it.
Handle the material with clean and grease-free hands.
Handle cylinders of 50 liters or more with clean handling gloves and safety shoes.
Check at the time of delivery by the manufacturer that the cylinder is equipped with an intact tamper-evident system.
Never handle a cylinder whose valve is not protected by a tulip, except in cylinders with a capacity less than 5 liters.
Never lift the cylinder by holding the valve.
Use connections or flexible connection elements specifically designed for oxygen.
Use a manoreducer with a flowmeter that can withstand a pressure of at least 1.5 times the maximum service pressure (200 bar) of the cylinder (unless there is already a built-in reducer on the valve).
In the case of cylinder racks, use only manometers graduated to at least 315 bar.
Use flexible connection elements in wall outlets equipped with oxygen-specific nozzles.
Open the valve or valve progressively.
Never force the valve to open, nor open it all the way.
Purge the cylinder outlet connection before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the cylinder and the manoreducer clean.
Never subject the manoreducer to several successive pressurizations.
Never place yourself in front of the valve outlet, but always on the opposite side of the manoreducer, behind the cylinder, and backwards. Never expose patients to the gas flow.
Never use intermediate connections to allow the connection of two devices that do not fit together.
Do not attempt to repair a faulty valve.
Never tighten the manoreducer - flowmeter with pliers, under the risk of causing damage to the gasket.
Check in advance the compatibility of materials in contact with oxygen, using in particular oxygen-specific connection gaskets for the manoreducer.
Close the cylinder valve after use, allow the manoreducer pressure to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated manoreducers) the manoreducer regulation screw.
In case of leakage, close the valve or supply circuit valve that has a leak. Never use a cylinder that has a leak, and check that the emergency device is activated.
Never completely empty a cylinder.
Keep empty cylinders with the valve closed and empty racks with the valve closed (to avoid corrosion processes in the presence of humidity).
Never transfer gas under pressure from one cylinder to another.
Ventilate the place of use if possible, if it is a reduced location (vehicles, home).

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