Medicinal oxygen gas Oximesa 200 bar, compressed medicinal gas, in gas cylinder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oximesa Medicinal Oxygen 200 bar Compressed Medicinal Gas in Gas Cylinder

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 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, pharmacist or nurse, even if they are adverse effects not listed in this leaflet.

Leaflet contents

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

1. What Oxígeno Medicinal Gas Oximesa is and what it is used for

Oxígeno Medicinal Gas Oximesa 200 bar medicinal compressed gas in gas cylinders is an inhalation gas packaged in gas cylinders at a pressure of 200 bar at 15°C. It contains oxygen at a concentration greater than 99.5%.

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 elevated pressure.
• Supplying anaesthesia-reanimation ventilators.
• Nebuliser administration of medications for inhalation.
• Treatment of acute attacks of cluster headache (a specific type of headache causing short but very severe episodes on one side of the head).

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

Do not use Oxígeno Medicinal Gas Oximesa

This medicinal product must not be used under high pressure in cases of untreated lung collapse (untreated pneumothorax). A lung collapse is an accumulation of gas in the pleural cavity between the two lung membranes. If you have previously experienced a lung collapse, inform your doctor.

Warnings and precautions:

Talk to your doctor, pharmacist, or nurse before starting to use Oxígeno Medicinal Gas Oximesa.

You must inform your doctor if you suffer from a chronic lung disease such as bronchitis, emphysema, or asthma, or if you are in a serious condition of oxygen deficiency.

Do not apply any greasy substances (e.g., vaseline, ointments, etc.) to the face due to the risk of inflammation of this medicinal product (see section 6).

In certain severe cases of oxygen deficiency, pulmonary or neurological toxicity may occur after 6 hours of exposure to 100% oxygen concentration or after 24 hours of exposure to oxygen concentrations above 70% (see sections 3 and 6). Therefore, high oxygen concentrations should be used for the shortest possible duration and monitored by arterial blood gas analysis, while simultaneously measuring the concentration of inhaled oxygen. It is advisable to always use the lowest effective dose capable of maintaining arterial partial pressure of oxygen (PaO₂) at 50–60 mm Hg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, the inhaled oxygen concentration should be kept, as far as possible, below 45%.

Oxygen is not a substitute for other prescribed medications for the treatment of cluster headache.

Precautions for use

• This medicinal product must not be used in the presence of flammable materials: oils, lubricants, fabrics, wood, paper, plastic materials (see section 6).

• When oxygen is administered under high pressure (hyperbaric oxygen therapy), injuries may occur due to high pressure in body cavities containing air that communicate with the outside. To avoid risks, compression and decompression must be performed slowly (see section 4).

• If you are to receive high-pressure oxygen therapy (hyperbaric oxygen therapy), you must inform your doctor if any of the following apply to you:

• If you have COPD (chronic obstructive pulmonary disease).

• If you have a lung disorder caused by loss of elasticity of lung tissue accompanied by severe respiratory difficulty (pulmonary emphysema).

• If you have an upper respiratory tract infection.

• If you have recently undergone middle ear surgery.

• If you have ever had thoracic surgery.

• If you have uncontrolled high fever.

• If you have severe epilepsy.

• If you suffer from fear of enclosed spaces (claustrophobia).

• If you have previously experienced a lung collapse (accumulation of air or gas in the pleural cavity between the two lung membranes (pneumothorax)).

Children:

In newborns, especially premature infants, retrolental fibroplasia (eye damage) may occur with certain oxygen concentrations.

In infants requiring oxygen concentrations above 30%, arterial partial pressure of oxygen (PaO₂) must be monitored regularly to ensure it does not exceed 100 mm Hg (i.e., 13.3 kPa).

Use of Oxígeno Medicinal Gas Oximesa 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 medicinal product.

This medicinal product has been widely used without any notable adverse effects.

Driving and using machines

There are no data available regarding the effects of Oxígeno Medicinal Gas Oximesa on driving or operating machinery.

3. How to use Oximesa Medicinal Oxygen Gas

Follow exactly the administration instructions for this medicine given by your doctor, pharmacist, or nurse. If you have any doubts, consult your doctor or pharmacist again.

Your doctor will determine the correct dose of Oximesa Medicinal Oxygen Gas and will administer it using a system appropriate to your needs, ensuring delivery of the correct amount of oxygen.

If you feel that the effect of Oximesa Medicinal Oxygen Gas is too strong or too weak, inform your doctor.

If you use more Oximesa Medicinal Oxygen Gas than you should:

In case of overdose or accidental ingestion, 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 ingested.

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

4. Possible adverse effects

Like all medicines, Oxígeno Medicinal Gas Oximesa may produce adverse effects, although not everyone will experience them.

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

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

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

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

Lung injuries may occur following administration of oxygen concentrations exceeding 80%.

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

Other adverse effects in children

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

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

Reporting of adverse effects

If you experience any type of adverse effect, talk to your doctor, pharmacist, or nurse, even if they are possible adverse effects not mentioned in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Oximesa Medicinal Oxygen Gas

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 followed.

The following considerations apply to storage and transport:

Storage of gas cylinders:

Gas cylinders must be stored in well-ventilated or aired premises, protected from adverse weather conditions, clean, free from flammable materials, reserved exclusively for the storage of medical gases, and capable of being locked.

Empty and full gas cylinders must be stored separately.

Gas cylinders must be protected against impact or falling, as well as from sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

Gas cylinders with a capacity greater than 5 l must be kept in an upright position, with valves closed.

Storage of gas cylinders at user facilities and in domestic settings:

The gas cylinder must be installed in a location that protects it from impact or falling (e.g., using a stand with securing elements), 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 gas cylinders:

Gas cylinders must be transported using appropriate equipment (e.g., a trolley equipped with chains, barriers, or rings) to protect them from impact or falling. Special attention must be paid to securing the pressure regulator to prevent accidental rupture.

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

6. Contents of the container and other information

Composition of Medicinal Oxygen Gas Oximesa

• The active substance is Oxygen
• Contains no excipients

Appearance of the product and contents of the container

• Gas cylinders

Gas cylinders are seamless steel or aluminum, available in various sizes. The cylinders are identified by colors defined by legislation specific to the product; at the time of this revision, these are a white body and white shoulder.

• Cylinder packs (manifolded cylinder bundles)

All gas cylinders are seamless steel and are interconnected via a copper manifold with a single common outlet valve. The group of cylinders is assembled within a protective metal frame forming the cylinder pack.

• Sizes

The following table lists the different sizes classified by their geometric capacity in liters and the gas content at a filling pressure of 200 bar at 15°C:

• 1 L cylinder providing 0.21 m³ of gas
• 2 L cylinder providing 0.42 m³ of gas
• 3 L cylinder providing 0.64 m³ of gas
• 3.4 L cylinder providing 0.72 m³ of gas
• 5 L cylinder providing 1.06 m³ of gas
• 5 L cylinder with integrated pressure and flow regulator providing 1.06 m³ of gas
• 7 L cylinder providing 1.48 m³ of gas
• 10 L cylinder providing 2.12 m³ of gas
• 13 L cylinder providing 2.76 m³ of gas
• 20 L cylinder providing 4.24 m³ of gas
• 30 L cylinder providing 6.36 m³ of gas
• 40 L cylinder providing 8.48 m³ of gas
• 50 L cylinder providing 10.60 m³ of gas
• Pack of 12 × 50 L cylinders providing 127.20 m³ of gas
• Pack of 16 × 50 L cylinders providing 169.60 m³ of gas
• Pack of 28 × 50 L cylinders providing 296.80 m³ of gas

Not all container sizes may be marketed.

• Outlet devices

The gas cylinder or cylinder pack is equipped at its outlet with:

• A brass valve or tap with standardized thread for oxygen use, to which either a pressure-reducing regulator will be attached to adjust to the required working pressure, or a connecting hose for fixed pipeline installations with regulation and control. This final system will be connected to network accessories or equipment at the preset pressure.
• In some small cylinders, an integrated valve with flow regulator and flowmeter for direct connection to accessories.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

NIPPON SANSO ESPAÑA S.L.U.
C/Orense, 11
28020 Madrid
Spain

Manufacturer:

NIPPON GASES ESPAÑA S.L.U.
Barrio de Occidente, S/N
14005- Córdoba
Spain

OR

NIPPON GASES ESPAÑA S.L.U.
C/ Riu Vinalopó, 67
46930- Quart de Poblet (Valencia)
Spain

OR

NIPPON GASES ESPAÑA S.L.U.
Calle de Embajadores, 474, Villaverde
28053 Madrid
Spain

OR

NIPPON GASES ESPAÑA S.L.U.
Polígono Industrial Somonte II
33393- Gijón (Asturias)
Spain

OR

OXIMESA, S.L.
Polígono Juncaril, Parcela 303
18220- Albolote (GRANADA)
Spain

OR

NIPPON GASES PORTUGAL, UNIPESSOAL, LDA.
Rua do Espído, S/N
4470-177 Maia (PORTUGAL)

Date of latest revision of this leaflet: July 2015

Detailed 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.

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 a device suspected of containing combustible materials, especially those of a greasy nature.
• Never clean devices containing this gas, or taps, seals, packings, closure devices, or valves, with flammable products, especially those of a greasy nature.
• Do not apply greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosols (hair spray, deodorants, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

Medicinal oxygen cylinders are reserved exclusively for therapeutic use.

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

1. Check the equipment is in good condition before use.
2. Securely fasten cylinders with a capacity greater than 5 L using appropriate means (chains, hooks, etc.) to keep them upright and prevent unexpected falls.
3. Do not use cylinders if their pressure is below 10 bar.
4. Never force a cylinder into a support too narrow for it.
5. Handle equipment with clean hands, free from grease.
6. Handle 50 L or larger cylinders with clean handling gloves and safety shoes.
7. At the time of delivery by the manufacturer, verify that the cylinder is equipped with an intact tamper-proof seal.
8. Do not handle a cylinder whose valve is not protected by a cap, except for cylinders with a capacity below 5 liters.
9. Never lift a cylinder by its valve.
10. Use connections or flexible connecting elements specifically designed for oxygen.
11. Use a pressure-reducing regulator with a flowmeter capable of withstanding at least 1.5 times the cylinder’s maximum service pressure (200 bar), unless the valve already incorporates a built-in reducer.
12. For cylinder packs, use only pressure gauges calibrated to at least 315 bar.
13. Use flexible connecting hoses on wall outlets equipped with oxygen-specific nozzles.
14. Open the valve or tap gradually.
15. Never force the valve to open, nor open it fully.
16. Purge the cylinder outlet connection before attaching the pressure regulator to remove any dust. Keep connections between the cylinder and regulator clean.
17. Never subject the pressure regulator to repeated pressurization cycles.
18. Never stand directly in front of the valve outlet; always position yourself on the side opposite the regulator, behind the cylinder and facing backward. Never expose patients directly to the gas flow.
19. Do not use intermediate connectors to join two devices that do not fit together.
20. Do not attempt to repair a defective valve.
21. Never tighten the pressure regulator–flowmeter with pliers, as this may damage the seal.
22. Verify in advance the compatibility of materials in contact with oxygen, particularly by using oxygen-specific seals for the regulator connections.
23. After use, close the cylinder valve, allow the pressure in the regulator to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except for integrated regulators) the pressure-adjusting screw on the regulator.
24. In case of leakage, close the valve or supply valve of the circuit with the integrity defect and verify that the emergency device is activated.
25. Never completely empty a gas cylinder.
26. Store empty cylinders with the valve closed, and empty cylinder packs with the valve closed (to prevent corrosion in the presence of moisture).
27. Never transfer pressurized gas from one cylinder to another.
28. Ventilate the area of use whenever possible, especially in confined spaces (vehicles, homes).