Medicinal oxygen gas Oxigen Salud 99.5% v/v compressed medicinal gas 300 bar

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxígeno Medicinal Gas Oxigen Salud 99.5 % v/v compressed medicinal gas 300 bar

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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must not give it 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, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

1. What Oxígeno Medicinal Gas Oxigen Salud is and what it is used for
2. What you need to know before using Oxígeno Medicinal Gas Oxigen Salud
3. How to use Oxígeno Medicinal Gas Oxigen Salud
4. Possible side effects
5. Storage of Oxígeno Medicinal Gas Oxigen Salud
6. Contents of the pack and other information

1. What Oxígeno Medicinal Gas Oxigen Salud 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 ventilators.
• Administration via nebulizer of medications for inhalation.

2. What you need to know before starting to use Oxígeno Medicinal Gas Oxigen Salud

Do not use Oxígeno Medicinal Gas Oxigen Salud:

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 compounds, especially those of a greasy nature (lubricants, oils), and organic materials (plastics, wood, paper, fabrics), 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 Gas Oxigen Salud:

• In certain severe cases of oxygen deficiency. After 6 hours of exposure to a 100% oxygen concentration, or after 24 hours of exposure to an oxygen concentration above 70%, pulmonary or neurological toxicity may occur.

• High concentrations should be used for the shortest possible time and monitored by arterial blood gas analysis, while simultaneously measuring the inhaled oxygen concentration; in any case, it is advisable to use the lowest dose capable of maintaining the arterial partial pressure of oxygen (PaO2) at 50–60 mm Hg (i.e., 5.65–7.96 kPa), and after 24 hours of exposure, to maintain, as far as possible, a concentration below 45%.

• For infants requiring a concentration above 30%, the arterial partial pressure of oxygen (PaO2) must be regularly monitored to ensure it does not exceed 100 mmHg (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 that communicate with the outside, compression and decompression must be performed slowly.

Use of Oxígeno Medicinal Gas Oxigen Salud 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, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist 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 Oxigen Salud on driving and operating machinery.

3. How to use Oxígeno Medicinal Gas Oxigen Salud

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

Your doctor will determine the correct dose of Oxígeno Medicinal Gas Oxigen Salud and 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 Oxígeno Medicinal Gas Oxigen Salud is too strong or too weak, inform your doctor.

The route of administration is by inhalation.

If you use more Oxígeno Medicinal Gas Oxigen Salud than you should

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.

In case of overdose, the concentration of inhaled oxygen should be reduced and symptomatic treatment is recommended.

If you forget to use Oxígeno Medicinal Gas Oxigen Salud

Do not use a double dose to make up for missed doses.

If you stop treatment with Oxígeno Medicinal Gas Oxigen Salud

If you have any further questions about the use of this medicine, ask your doctor, pharmacist, or nurse.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everyone will experience them.

In particular, in chronic respiratory failure, there is a possibility of developing apnea (cessation of breathing while the person is asleep).

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

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

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

Pulmonary injury may occur following administration of oxygen concentrations exceeding 80%.

In newborns, especially if premature, exposure to high oxygen concentrations (FiO2 > 40%; PaO2 greater than 80 mmHg (i.e., 10.64 kPa)) or prolonged exposure (more than 10 days at 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 therapy in chambers may experience claustrophobia episodes.

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es

By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Medicinal Oxygen Gas Oxigen Salud

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

Do not use this medicine after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.

All regulations concerning the handling of pressurized containers and the instructions for your specific equipment must be followed.

The following considerations apply regarding storage and transport:

Storage of cylinders:

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

Empty and full cylinders must be stored separately.

Cylinders must be protected from impact or falling risks, as well as from sources of heat or ignition, 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 risks of impact or falling (such as a stand with securing chains), sources of heat or ignition, 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.

Medicines must not be disposed of via wastewater or household waste. Return unused medicines and empty containers to the SIGRE collection point at your pharmacy. If you have any doubts, ask your pharmacist how to properly dispose of unused medicines and their containers. This helps protect the environment.

6. Contents of the container and other information

Composition of Oxígeno Medicinal Gas Oxigen Salud

• The active substance is Oxygen 99.5% v/v

Appearance of the product and contents of the container

Oxígeno Medicinal Gas Oxigen Salud is an inhalation gas packaged in gas cylinders at a pressure of 300 bar at 15°C. The cylinders may be made of steel, compact steel, aluminum, or compact aluminum, with the following volumes:

• 1 L cylinder providing 0.306 m³ of gas, equivalent to 414 g of packaged product
• 2 L cylinder providing 0.611 m³ of gas, equivalent to 827 g of packaged product
• 2.7 L cylinder providing 0.825 m³ of gas, equivalent to 1,118 g of packaged product
• 3 L cylinder providing 0.917 m³ of gas, equivalent to 1,240 g of packaged product
• 4.7 L cylinder providing 1.438 m³ of gas, equivalent to 1,945 g of packaged product
• 5 L cylinder providing 1.53 m³ of gas, equivalent to 2,070 g of packaged product
• 7 L cylinder providing 2.14 m³ of gas, equivalent to 2,890 g of packaged product
• 10 L cylinder providing 3.06 m³ of gas, equivalent to 4,140 g of packaged product
• 13 L cylinder providing 3.97 m³ of gas, equivalent to 5,380 g of packaged product
• 15 L cylinder providing 4.58 m³ of gas, equivalent to 6,200 g of packaged product
• 16 L cylinder providing 4.89 m³ of gas, equivalent to 6,620 g of packaged product
• 20 L cylinder providing 6.11 m³ of gas, equivalent to 8,270 g of packaged product
• 30 L cylinder providing 9.17 m³ of gas, equivalent to 12,410 g of packaged product
• 40 L cylinder providing 12.22 m³ of gas, equivalent to 16,540 g of packaged product
• 50 L cylinder providing 15.28 m³ of gas, equivalent to 20,680 g of packaged product
• Block of 12 x 50 L cylinders providing 183.3 m³ of gas, equivalent to 248,100 g of packaged product
• Block of 16 x 50 L cylinders providing 244.5 m³ of gas, equivalent to 330,900 g of packaged product

Only certain cylinder sizes may be commercially available.

Marketing Authorization Holder

OXIGEN SALUD, S.A.
Carretera Rubí 141-143
08174 Sant Cugat del Vallés (Barcelona)

Manufacturer

OXIGEN SALUD, S.A.
Polígono Industrial, Calle A, Parcela 63
09320 Madrigal del Monte (Burgos)

OR

OXIGEN SALUD, S.A.
Carretera Rubí 141-143
08174 Sant Cugat del Vallés (Barcelona)

Date of the most recent review of this leaflet: November 2022

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.es/

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This information is intended exclusively for healthcare professionals

Instructions for use/handling

Do not smoke.
Do not bring near flames.
Do not grease.

In particular:

• Never introduce this gas into equipment suspected of containing combustible materials, especially those of a greasy nature;
• Never clean equipment containing this gas, or taps, seals, packings, closure devices, and valves with flammable products, especially those of a greasy nature;
• 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 or near the equipment.

Medical oxygen cylinders are reserved exclusively for therapeutic use.

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

1. Check the equipment is in good condition before use.
2. Secure cylinders with a capacity greater than 5 L in an upright position using appropriate means (chains, hooks, etc.) to prevent accidental falls; do not use cylinders if their pressure is below 10 bar.
3. Never force a cylinder into a holder that is too narrow.
4. Handle equipment with clean, grease-free hands.
5. Handle cylinders of 50 L or more with clean handling gloves and safety shoes.
6. At the time of delivery by the manufacturer, verify that the cylinder is equipped with an intact tamper-proof seal.
7. Do not handle a cylinder whose tap is not protected by a cap, except for cylinders with a capacity below 5 L.
8. Never lift the cylinder by the tap.
9. Use connections or flexible connection components specifically designed for oxygen.
10. Use pressure regulators that are certified and comply with current regulations.
11. Use a pressure regulator with a flowmeter capable of withstanding a pressure of at least 1.5 times the cylinder's maximum service pressure (300 bar), unless the tap already includes an integrated regulator.
12. For cylinder blocks, use only pressure gauges graduated to at least 315 bar.
13. Use connectors or flexible connection components on wall outlets equipped with oxygen-specific nozzles and terminations.
14. In case of leakage, close the tap or supply valve of the circuit.
15. Never use a container showing leakage or loss of tightness.
16. Open the tap or valve gradually.
17. Never force the tap to open it, nor open it fully.
18. 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.
19. Never subject the pressure regulator to repeated pressurizations.
20. Never stand directly in front of the tap outlet; always stand on the side opposite the pressure regulator, behind the cylinder and away from it. Never expose patients to the gas flow.
21. Do not use intermediate adapters to connect two devices that are not compatible.
22. Never attempt to repair a defective tap.
23. Never tighten the pressure regulator–flowmeter with pliers, as this may damage the seal.
24. Check in advance the compatibility of materials in contact with oxygen, using in particular oxygen-specific seals for the pressure regulator connections.
25. After use, close the cylinder tap, allow the pressure in the regulator to dissipate by leaving the flowmeter open, then close the flowmeter and loosen (except for integrated pressure regulators) the pressure regulator adjustment screw.
26. In case of leakage, close the tap or supply valve of the circuit showing loss of tightness. Never use a cylinder showing loss of tightness, and ensure the emergency device is activated.
27. Never completely empty a cylinder.
28. Store empty cylinders with the tap closed and empty frames with the valve closed (to prevent corrosion in the presence of moisture).
29. Never transfer pressurized gas from one cylinder to another.

Ventilate the area of use if possible, especially in confined spaces (vehicles, homes).