Medicinal oxygen gas Nippon Gases 200 bar compressed medicinal gas in gas cylinder

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Oxígeno Medicinal Gas Nippon Gases 200 bar medicinal compressed gas in gas cylinder

Oxygen

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, 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, since it may harm them.
• If you experience any adverse reactions, consult your doctor, pharmacist or nurse, even if they are adverse reactions not listed in this leaflet.

Leaflet contents

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

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

3. How to use Oxígeno Medicinal Gas Nippon Gases.

4. Possible side effects.

5. How to store Oxígeno Medicinal Gas Nippon Gases.

6. Contents of the pack and other information.

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

Oxígeno Medicinal Gas Nippon Gases 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-resuscitation ventilators.
• Administration via nebulizer of inhaled medications.
• 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 Nippon Gases

Do not use Oxígeno Medicinal Gas Nippon Gases

This medicine 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 suffered a lung collapse, inform your doctor.

Warnings and precautions:

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

You must inform your doctor if you have 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 (vaseline, ointments, etc.) to the face due to the risk of inflammation with this medicine (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 time and monitored by arterial blood gas analysis, while simultaneously measuring the inhaled oxygen concentration. It is advisable to always use the lowest 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, it is recommended to maintain, as far as possible, an oxygen concentration below 45%.

Oxygen is not a substitute for other prescribed medications used to treat cluster headache.

Precautions for use:

• This medicine must not be used in the presence of flammable materials: oils, lubricants, fabrics, wood, paper, plastic materials (see section 6).
• If 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:
  • You have COPD (chronic obstructive pulmonary disease).
  • You have a lung disorder caused by loss of elasticity of lung tissue accompanied by severe breathing difficulty (pulmonary emphysema).
  • You have an upper respiratory tract infection.
  • You have recently undergone middle ear surgery.
  • You have previously undergone thoracic surgery.
  • You have uncontrolled high fever.
  • You have severe epilepsy.
  • You suffer from fear of enclosed spaces (claustrophobia).
  • 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, eye damage (retrolental fibroplasia) may occur with certain oxygen concentrations.

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

Other medicines and Oxígeno Medicinal Gas Nippon Gases

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, 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.

This medicine has been widely used without any notable adverse effects.

Driving and use of machines

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

3. How to use Oxígeno Medicinal Gas Nippon Gases

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

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

If you consider the effect of Oxígeno Medicinal Gas Nippon Gases to be too strong or too weak, inform your doctor.

If you use more Oxígeno Medicinal Gas Nippon Gases 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 case of overdose, the concentration of inhaled oxygen should be reduced and symptomatic treatment is recommended.

4. Possible adverse effects

Like all medicines, Medicinal Oxygen Gas Nippon Gases may produce adverse effects, although not everyone will experience 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 after administration of 100% oxygen concentration for more than 6 hours, particularly when administered under high pressure.

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

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

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 retrolental 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, consult your doctor, pharmacist, or nurse, even if they are possible adverse effects not listed in this leaflet. You may 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 Nippon Gases

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 relating to the handling of pressurized containers must be followed.

The following considerations apply regarding storage and transport:

Storage of gas cylinders:

Gas cylinders must be stored in well-ventilated or ventilated areas, protected from weather conditions, clean, free from flammable materials, reserved for the storage of medical gases, and capable of being secured with a lock.

Empty gas cylinders and full gas cylinders must be stored separately.

Gas cylinders must be protected from 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 (such as 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 (such as 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. 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 Nippon Gases

• The active substance is Oxygen.
• It contains no excipients.

Appearance of the product and pack contents

• Gas cylinders

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

• Cylinder manifolds (gas cylinder banks)

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

• Sizes

The following are 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
• 1.5 L cylinder providing 0.32 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, flow, and regulation valve 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
• Manifold of 12 × 50 L cylinders providing 127.20 m³ of gas
• Manifold of 16 × 50 L cylinders providing 169.60 m³ of gas
• Manifold of 28 × 50 L cylinders providing 296.80 m³ of gas

Not all pack sizes may be marketed.

• Outlet devices

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

• A brass valve or tap with standardized threading for oxygen use, to which either a pressure-reducing regulator will be attached to adjust the pressure for use, or a flexible hose for connection to a fixed installation with centralized regulation and control. This final system will be connected to network accessories or equipment at the preset pressure.
• In some small gas cylinders, an integrated flow and pressure regulator 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 Embajadores 474, Villaverde
28053 Madrid
Spain

Or

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

Or

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

Date of the most recent revision of this leaflet: August 2019

Detailed information on this medicinal product is available on the website of the Spanish Agency for 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 an open flame.
Do not grease.

In particular:

• Never introduce this gas into any device suspected of containing combustible materials, especially those of a greasy nature.
• Never clean devices containing this gas, or taps, seals, gaskets, closure devices, or valves, with flammable products, especially those of a greasy nature.
• Do not apply any greasy substances (e.g., 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.

Medicinal oxygen cylinders are intended 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 using appropriate means (chains, hooks, etc.) to keep them upright and prevent unexpected falls.

3. Do not use cylinders if the internal pressure is below 10 bar.

4. Never force a cylinder into a holder that is too narrow.

5. Handle equipment with clean hands, free from grease.

6. Handle 50 L cylinders or larger using clean handling gloves and safety shoes.

7. At 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 connection elements specifically designed for oxygen.

11. Use a pressure-reducing 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 valve already incorporates a built-in reducer.

12. For cylinder manifolds, use only pressure gauges calibrated to at least 315 bar.

13. Use flexible connection elements on wall outlets equipped with nozzles specifically designed for oxygen.

14. Open the valve or tap gradually.

15. Never force the valve to open it, nor open it fully.

16. Purge the cylinder outlet connection before attaching the pressure-reducing regulator to remove any dust. Keep connections between the cylinder and the regulator clean.

17. Never subject the pressure-reducing regulator to repeated pressurizations.

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 adapters to connect devices that are not compatible.

20. Do not attempt to repair a defective valve.

21. Never tighten the pressure-reducing regulator–flowmeter with pliers, as this may damage the seal.

22. Always verify 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 dissipate by leaving the flowmeter open, then close the flowmeter and (except for integrated regulators) loosen the regulator’s adjustment screw.

24. In case of leakage, close the supply valve or tap of the affected circuit, and verify that the emergency system is activated.

25. Never completely empty a gas cylinder.

26. Store empty cylinders with the valve closed, and empty cylinder manifolds with the main 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 if possible, especially in confined spaces (vehicles, homes).