Oxigeno medicinal gas sapio life 99,5% v/v gas comprimido medicinal

Leaflet: information for the user

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

- This medicine has been prescribed for you only and should not be given to other people, even if they have the same symptoms, as it may harm them.

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

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

2. What you need to know before starting to use Oxygen Medicinal Gas Sapio Life

3. How to use Oxygen Medicinal Gas Sapio Life

4. Possible side effects

5. Storage of Oxygen Medicinal Gas Sapio Life

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 ventilators in anesthesia - resuscitation.
• Administration via nebulizer of medications for inhalation.

No use Oxígeno Medicinal 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 of use of the gas.

However, the most important risks of inflammation in the presence of oxygen are associated with combustible materials, especially those of fatty nature (oils, lubricants) and organic materials (tissues, wood, paper, plastic materials...) that can ignite upon 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 Oxygen medicinal 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) greater than 70%, pulmonary or neurological toxicity may appear.

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

Precautions for use

For infants who need an oxygen concentration (FiO2) greater than 30%, the PaO2 concentration should be regularly controlled to prevent it from exceeding 100 mm Hg (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 Oxygen Medicinal Gas Sapio Lifewith 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

If you are pregnant or breastfeeding, or if you think you may be pregnant or intend to become pregnant, consult your doctor before using this medication.

It has been widely used without any notable effect.

Driving and use of machines

There are no data on the effect of Oxygen Medicinal Gas Sapio Life 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 Medical Oxygen Gas Sapio Lifeand administer it to you through an appropriate system tailored to your needs, which will ensure the supply of the correct amount of oxygen.

If you estimate that the action of Medical Oxygen Gas Sapio Lifeis too strong or weak, inform your doctor.

If you use more Medical Oxygen Gas Sapio Lifethan you should

Reduce the concentration of inhaled oxygen and symptomatic treatment is recommended.

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.

Like all medications, Medical Oxygen Gas Sapio Lifemay produce adverse effects, although not all people will experience them.

In particular, chronic respiratory insufficiency, possibility of apnea occurrence.

Inhalation of high oxygen concentrations may cause small lung collapses.

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

Seizures have been registered after oxygen administration with a concentration (FiO2) of 100 % for more than 6 hours, particularly with high-pressure administration. Lung injuries may occur after administration of oxygen concentrations (FiO2) above 80 %.

In newborns, particularly if premature, exposed to strong oxygen concentrations (FiO2>40 %; PaO2above 80 mm Hg (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, possibly experiencing regression or causing retinal detachment, or even permanent blindness.

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

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

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

Do not use this medication after the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

All guidelines related to the handling of pressurized containers must be followed.

The following must be taken into account in relation to storage and transportation:

Storage of the cylinders:

The cylinders must be stored in a well-ventilated or ventilated area, protected from the elements, clean, free from flammable materials, reserved for the storage of medical gases and capable of being locked.

Empty and full cylinders must be stored separately.

The cylinders must be protected from the risk of impacts or falls, as well as from heat sources or ignition, temperatures equal to or greater than 50°C, and combustible materials and weather conditions. Cylinders with a capacity greater than 5 liters must be kept in an upright position, with the valves closed.

Storage of the 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 impacts and falls (such as a support with fixing chains), heat sources or ignition, temperatures equal to or greater than 50°C, combustible materials, and weather conditions.

Excessive storage must be avoided.

Transportation of the cylinders:

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

Special attention must also be given to securing the reducer to avoid accidental ruptures.

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

Composition of Medical Oxygen Gas Sapio Life

The active ingredient is Oxygen, in a concentration greater than 99.5% v/v

Appearance of the product and contents of the packaging

It is packaged in cylinders at 200 bars of pressure at 15°C. The cylinders can be made of steel, compact steel, aluminum, or compact aluminum of 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 packaging sizes may be commercially available

Instructions for use / handling

Do not smoke.

Do not approach a flame.

Do not lubricate.

Specifically:

• Never introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are of a greasy nature;

• Never clean with combustible products, especially if they are of a greasy nature, nor the apparatuses that contain this gas nor the faucets, joints, gaskets, closure devices, and valves;

• Never apply any greasy substance (vaseline, ointments...) to the patients' faces;

• Never use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or nearby.

The oxygen medical cylinders are exclusively reserved for therapeutic use.

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

1. Verify the good condition of the material before its use.
2. Group the cylinders with a capacity greater than 5 liters with an appropriate medium (chains, hooks, ...) to keep them in a vertical position and avoid any sudden fall; do not use the cylinders if their pressure is less than 10 bars.
3. Never force a cylinder into a too narrow support for it.
4. Manipulate the material with clean and grease-free hands.
5. Manipulate the 50-liter or larger cylinders with clean handling gloves and safety shoes.
6. Verify in advance, at the time of delivery by the manufacturer, that the cylinder is provided with an intact inviolability guarantee system.
7. Do not manipulate a cylinder whose valve is not protected by a tulip, except for cylinders with a capacity less than 5 liters.
8. Do not lift the cylinder by the valve.
9. Use specific oxygen connections or flexible connection elements.
10. Use a pressure reducer with a flowmeter that can accommodate a pressure of at least 1.5 times the maximum service pressure (200 bars) of the cylinder (except if there is already a built-in reducer on the valve).
11. In the case of cylinder racks, use only pressure gauges graduated at least to 315 bars.
12. Use flexible connection elements on wall-mounted outlets provided with specific oxygen nozzles.
13. Open the valve or valve gradually.
14. Never force the valve to open it, nor open it completely.
15. Purge the outlet connection of the cylinder before incorporating the pressure reducer to eliminate any dust that may have accumulated. Keep the connections between the cylinder and the pressure reducer clean.
16. Never subject the pressure reducer to multiple successive pressurizations.
17. Never position yourself in front of the valve outlet, but always on the opposite side of the pressure reducer, behind the cylinder and towards the back. Never expose patients to the gas flow.
18. Never use intermediate connections to allow the connection of two devices that do not fit together.
19. Do not attempt to repair a defective valve.
20. Never clamp the pressure reducer-flowmeter with pliers, under risk of causing damage to the joint.
21. Verify in advance the compatibility of the materials in contact with oxygen, using in particular special connection joints for the pressure reducer.
22. Close the cylinder valve after use, allow the pressure in the pressure reducer to decrease while keeping the flowmeter open, close the flowmeter and then loosen (except in the case of integrated pressure reducers) the adjustment screw of the pressure reducer.
23. In case of a leak, close the valve or the feeding valve of the defective circuit. Never use a cylinder that presents a leak, and check that the emergency device is activated.
24. Never empty a cylinder completely.
25. Store empty cylinders with the valve closed and empty racks with the valve closed (to avoid corrosion processes in the presence of humidity).
26. Never transfer gas under pressure from one cylinder to another.
27. Ventilate the place of use if possible, especially in small locations (vehicles, home).

Authorized marketing titleholder

SAPIO LIFE, S.A.U.

Camino de lo Cortao, 28

San Sebastián de los Reyes

28709 Madrid

Responsible for manufacturing:

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.

Urbanización Industrial Salinetas

35219 – Telde (Gran Canaria)

or

S.E. de CARBUROS METÁLICOS, S.A.

Polígono Industrial Can Rubiol

C/ Celleters, 142

07141 Marratxí (Mallorca)

or

S.E. de CARBUROS METÁLICOS, S.A.

Ildefonso Carrascosa, Par. 20-21

Pol. Ind. Mediterráneo

46560 – Massalfasar (Valencia)

or

S.E. de CARBUROS METÁLICOS, S.A.

Crta. De Toledo, 7

28300 – Aranjuez (Madrid)

or

S.E. de CARBUROS METÁLICOS, S.A.

Barrio Chaco, s/n

48480 – Arrigorriaga (Vizcaya)

Last review date of this 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/