Oxygen Medicinal Liquid Sapio Life 99.5% V/V, medicinal cryogenic gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxígeno Medicinal Líquido Sapio Life 99.5% v/v medicinal cryogenic gas

Read all of this 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 you, because it could harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet.

Leaflet contents

1. What Oxígeno Medicinal Líquido Sapio Life is and what it is used for
2. What you need to know before using Oxígeno Medicinal Líquido Sapio Life
3. How to use Oxígeno Medicinal Líquido Sapio Life
4. Possible adverse effects
5. How to store Oxígeno Medicinal Líquido Sapio Life
6. Contents of the pack and other information

1. What Oxígeno Medicinal Líquido 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 oxygen administration at normal or increased pressure.
• Supplying anaesthesia and resuscitation ventilators.
• Administration via nebulizer of medications for inhalation.

2. What you need to know before starting to use Oxígeno Medicinal Líquido Sapio Life

Do not use Oxígeno Medicinal Líquido 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), which may ignite upon contact with oxygen, either spontaneously or due to a spark, flame, or ignition source, or as a result 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) above 70%, pulmonary or neurological toxicity may occur.

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

Precautions for use

For infants requiring an FiO2 concentration above 30%, PaO2 levels should be monitored regularly to ensure they do 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 Líquido Sapio Life with 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 anticancer drugs, 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 are planning 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 available on the effects of Oxígeno Medicinal Líquido Sapio Life on driving and operating machinery.

3. How to use Sapio Life Medicinal Liquid Oxygen

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 Sapio Life Medicinal Liquid Oxygen and will administer it through a system suitable for your needs, ensuring the delivery of the correct amount of oxygen.

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

If you use more Sapio Life Medicinal Liquid Oxygen 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 Liquid Oxygen Sapio Life may have 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 lung collapses.

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

Seizure episodes have been reported after administration of oxygen at a concentration (FiO₂) of 100% for more than 6 hours, particularly when administered under high pressure.

Pulmonary injuries may occur following administration of oxygen concentrations (FiO₂) exceeding 80%.

In newborns, especially if premature, exposure to high oxygen concentrations (FiO₂ >40%; PaO₂ greater than 80 mm Hg (i.e., 10.64 kPa)) or prolonged exposure (more than 10 days at an FiO₂ > 30%) carries a risk of retinopathy, appearing between 3 and 6 weeks after treatment, which may either regress or lead to retinal detachment or even permanent blindness.

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

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

5. Storage of Sapio Life Medicinal Liquid Oxygen

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 pressure vessels must be followed, as well as the instructions specific to your equipment.

The following considerations apply to storage and transport:

Evaporators, whether fixed or mobile, must be installed outdoors in a clean area free from flammable materials, designated exclusively for the storage of medical gases and secured with a lock.

Under no circumstances should open flames be used, smoking be permitted, or greasing be performed in the area. Parking is also prohibited in the transfer area. Risks associated with atmospheric over-oxygenation or oxygen enrichment of clothing must be monitored and controlled.

Fixed or mobile cryogenic evaporators and containers must be protected from impacts, particularly at the filling, emptying, and safety components (thin metal sheets, valves, pressure gauges), as well as from sources of heat or ignition, temperatures of 50 °C or higher, and combustible materials.

Mobile cryogenic evaporators and containers must never be laid down horizontally.

6. Contents of the container and other information

Composition of Sapio Life Medicinal Liquid Oxygen

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

Appearance of the product and contents of the container:

Sapio Life Medicinal Liquid Oxygen is an inhalation gas supplied in domestic cryogenic containers, cryogenic cylinders, or cryogenic isocontainers of various volumes, containing medicinal oxygen in liquid form, intended for subsequent transfer to portable containers for final administration to the patient in gaseous form.

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 cylinder:

230 L, 180 L.

Not all container sizes may be marketed.

Instructions for use / handling

It is important to read the equipment's instructions for use carefully.

Do not smoke.

Do not bring near flames.

Do not grease.

Primarily, never introduce this gas into any apparatus suspected of containing combustible materials, and especially greasy substances; never clean with flammable products, and especially with greasy substances, either the apparatus containing this gas or the valves, joints, linings, closure devices, and valves themselves.

• Check that the apparatus is in proper condition before use.
• Do not apply greasy products (e.g. vaseline, ointments) to the patient's face.
• Handle the apparatus with clean, grease-free hands.
• Do not use aerosol generators (hairspray, deodorants, etc.) or solvents (alcohol, gasoline, etc.) with or near the apparatus.
• In case of leakage, close the tap or valve supplying the circuit that is leaking. Never use a cylinder showing signs of leakage, and check the proper functioning of the auxiliary system.
• Ventilate the area of use whenever possible, especially in small spaces (vehicles, homes).
• Always carry out any handling of liquid oxygen containers wearing clean gloves suitable for this use and protective goggles.
• Never touch cold or frozen parts of the apparatus.
• In case of cryogenic burn, rinse thoroughly with water.
• Use oxygen-specific connectors.
• Evaporators and mobile cryogenic containers: during use of the flexible hoses, never exceed the maximum service pressure; do not bend the hose to an excessively small radius; never leave the hose on the floor; monitor the condition of the outer sheath; and never grease the hose.
• If clothing becomes saturated with oxygen, move away from the liquid oxygen source and from areas with fire hazards. Remove the clothing immediately.
• Do not use intermediate connectors to join two devices that do not fit together.
• Evaporator and mobile cryogenic container: open the tap or valve gradually.
• Provide overpressure safety devices in each liquid oxygen circuit where there is a risk of liquid becoming trapped between two valves.
• Use flexible connection components at wall outlets fitted with oxygen-specific nozzles.

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

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 latest revision of this leaflet:

August 2005

Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS) http://www.aemps.gob.es/