Medicinal oxygen gas 99.5% v/v compressed medicinal gas Sapio Life: detailed information

Brand name Medicinal oxygen gas 99.5% v/v compressed medicinal gas Sapio Life

Form gas, medicinal compressed

Active substance / Dosage

OXYGEN · 99,5 % V/V

Prescription type Hospital Use Only

ATC code

V03A V03AN V03AN01

Registration number 66964

Manufacturer Contse S.A.

Medicinal oxygen gas 99.5% v/v compressed medicinal gas Sapio Life gas, medicinal compressed

Table of Contents

Package leaflet: Information for the user
Introduction
1. What Oxígeno Medicinal Gas Sapio Life is and what it is used for
2. What you need to know before using Oxígeno Medicinal Gas Sapio Life
3. How to use Oxígeno Medicinal Gas Sapio Life
4. Possible adverse effects
5. Storage of Medicinal Oxygen Gas Sapio Life
6. Contents of the pack and other information

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Read the entire leaflet carefully before you start using this medicine, because it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any questions, ask your doctor or pharmacist.
This medicine has been prescribed for you only and must not be given to other people, 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 effects not listed in this leaflet.

Leaflet contents

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

1. What Oxígeno Medicinal Gas Sapio Life is and what it is 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 requiring administration of oxygen at normal or increased pressure.
Supplying anaesthesia and resuscitation respirators.
Administration via nebulizer of inhaled medications.

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

Do not use Oxígeno Medicinal Gas Sapio Life:

With flammable materials, oxygen supports and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the pressure conditions under which the gas is used.

However, the most significant fire risks in the presence of oxygen are associated with combustible substances, especially those of a greasy nature (oils, lubricants), and organic materials (fabrics, wood, paper, plastics, etc.), which may ignite upon contact with oxygen, either spontaneously or due to a spark, flame, or ignition point, or as a result of adiabatic compression.

Warnings and precautions

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

In certain severe cases of oxygen deficiency, pulmonary or neurological toxicity may occur 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%.

High oxygen concentrations should be used for the shortest possible time and monitored by arterial blood gas analysis, while simultaneously measuring the concentration of inhaled oxygen. In all cases, it is advisable to use the lowest dose capable of maintaining the PaO2 level at 50–60 mm Hg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, the FiO2 concentration should be kept below 45% whenever possible.

Precautions for use

For infants requiring an FiO2 concentration above 30%, the PaO2 concentration should be regularly monitored to ensure it does not exceed 100 mm Hg (i.e., 13.3 kPa) due to the risk of retinal damage.

Hyperbaric oxygen therapy: To avoid risks of injury caused by high pressure in body cavities containing air and communicating with the outside, compression and decompression must be performed slowly.

Use of Oxígeno Medicinal Gas Sapio Lifewith other medicines

Inform your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.

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

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 adverse effects.

Driving and use of machines

There are no data regarding the effect of Oxígeno Medicinal Gas Sapio Life on driving or operating machinery.

3. How to use Oxígeno Medicinal Gas Sapio Life

Follow exactly the administration instructions for this medicine given by your doctor. If in doubt, consult your doctor or pharmacist again.

Your doctor will determine the correct dose of Oxígeno Medicinal Gas Sapio Life and administer it using a system appropriate to your needs, which will ensure delivery of the correct amount of oxygen.

If you feel that the effect of Oxígeno Medicinal Gas Sapio Life is too strong or too weak, inform your doctor.

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

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

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

4. Possible adverse effects

Like all medicines, Medicinal Oxygen Gas Sapio Life may cause adverse effects, although not everyone experiences them.

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

Inhalation of high concentrations of oxygen may cause small collapses in the lung.

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

Seizure episodes have been reported following administration of oxygen at a concentration (FiO₂) of 100% for more than 6 hours, particularly when administered at high pressure. Pulmonary injuries may occur following administration of oxygen concentrations (FiO₂) exceeding 80%.

In newborns, especially if premature, exposed to high oxygen concentrations (FiO₂ > 40%; PaO₂ above 80 mm Hg (i.e., 10.64 kPa)) or for prolonged periods (more than 10 days at an FiO₂ > 30%), there is a risk of retinopathy, which may appear between 3 and 6 weeks after treatment. This condition may regress or may lead to retinal detachment or even permanent blindness.

Patients undergoing high-pressure oxygen therapy in chambers may experience episodes of claustrophobia.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if these adverse effects 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 stated on the container. The expiry date refers to the last day of the month indicated.

All regulations concerning the handling of pressurized containers must be observed.

The following considerations apply to storage and transport:

Storage of cylinders:

Cylinders must be stored in a well-ventilated or ventilated area, protected from adverse weather conditions, clean, free from flammable materials, designated exclusively for the storage of medical gases, and lockable.

Empty and full cylinders must be stored separately.

Cylinders must be protected from impact or falling, as well as from heat or ignition sources, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions. Cylinders with a capacity greater than 5 l must be kept in an upright position with valves closed.

Storage of cylinders at user facilities and in domestic settings:

The cylinder must be installed in a location that protects it from impact or falling risks (such as a support with securing chains), from heat or ignition sources, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

Excessive storage must be avoided.

Transport of cylinders:

Cylinders must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling risks.

Special attention must also be paid to securing the pressure regulator to prevent accidental breakage.

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

6. Contents of the pack and other information

Composition of Medicinal Oxygen Gas Sapio Life

The active substance is Oxygen, at a concentration exceeding 99.5% v/v.

Appearance of the product and contents of the pack

The gas is packaged in cylinders at a pressure of 200 bar at 15°C. The cylinders may be made of steel, compact steel, aluminum, or compact aluminum, with the following water capacities: 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 bring near a flame.

Do not grease.

In particular:

Never introduce this gas into any apparatus suspected of containing combustible materials, especially those of a greasy nature;
Never clean with flammable products, especially those of a greasy nature, either the apparatus containing this gas or taps, seals, gaskets, closure devices, and valves;
Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face;
Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the equipment or near it.

Medicinal oxygen cylinders are reserved exclusively for therapeutic use.

To prevent any accidents, the following instructions must be strictly observed:

Check the equipment is in good condition before use.
Securely group cylinders with a capacity greater than 5 liters using appropriate means (chains, hooks, etc.) to keep them in an upright position and prevent accidental falls; do not use cylinders if their pressure is below 10 bar.
Never force a cylinder into a holder that is too narrow.
Handle equipment with clean, grease-free hands.
Handle cylinders of 50 liters or more using clean handling gloves and safety shoes.
At the time of delivery by the manufacturer, verify that the cylinder is equipped with an intact tamper-proof seal.
Do not handle a cylinder whose tap is not protected by a cap, except for cylinders with a capacity below 5 liters.
Never lift the cylinder by the tap.
Use connections or flexible connection components specifically designed for oxygen.
Use a pressure regulator with a flowmeter capable of withstanding a pressure of at least 1.5 times the cylinder's maximum service pressure (200 bar), unless the tap already incorporates a built-in reducer.
For cylinder manifolds, use only pressure gauges calibrated to at least 315 bar.
Use flexible connection components on wall outlets fitted with nozzles specifically designed for oxygen.
Open the tap or valve gradually.
Never force the tap to open it, nor open it fully.
Purge the cylinder's outlet connection before attaching the pressure regulator to remove any dust. Keep the connections between the cylinder and the pressure regulator clean.
Never subject the pressure regulator to repeated pressurizations.
Never stand directly in front of the tap outlet; always stand on the side opposite the pressure regulator, behind the cylinder and slightly to the rear. Never expose patients directly to the gas flow.
Do not use intermediate connectors to connect two devices that do not fit together.
Do not attempt to repair a defective tap.
Never tighten the pressure regulator-flowmeter with pliers, as this may damage the seal.
Check in advance the compatibility of materials in contact with oxygen, using in particular pressure regulator connection seals specifically designed for oxygen.
After use, close the cylinder tap, allow the pressure in the pressure regulator to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated pressure regulators) the pressure regulator adjustment screw.
In case of leakage, close the tap or valve supplying the circuit with the integrity defect. Never use a cylinder showing a leak, and ensure the emergency device is activated.
Never completely empty a cylinder.
Store empty cylinders with the tap closed and empty manifolds with the valve closed (to prevent corrosion in the presence of moisture).
Never transfer pressurized gas from one cylinder to another.
If possible, ventilate the area of use, especially in confined spaces (vehicles, homes).

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