Oxygen medicinal liquid Nippon Gases 99.5% v/v, medicinal cryogenic gas in fixed cryogenic container

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Medicinal Liquid Oxygen Nippon Gases 99.5% v/v, medicinal cryogenic gas in fixed cryogenic container

Oxygen

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet; 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 could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if the effects are not listed in this leaflet.

Contents of this leaflet

1. What Medicinal Liquid Oxygen Nippon Gases is and what it is used for.

2. What you need to know before using Medicinal Liquid Oxygen Nippon Gases.

3. How to use Medicinal Liquid Oxygen Nippon Gases.

4. Possible side effects.

5. How to store Medicinal Liquid Oxygen Nippon Gases.

6. Contents of the pack and other information.

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

Oxígeno Medicinal Líquido Nippon Gases 99.5% v/v, gas for inhalation, is a gas for inhalation supplied in fixed cryogenic containers made of stainless steel with various capacities.

It contains oxygen at a concentration greater than 99.5% v/v.

It contains no other excipients.

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 respirators.
• Nebuliser administration 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 Nippon Gases Liquid Medical Oxygen

Do not use Nippon Gases Liquid Medical Oxygen

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 experienced a lung collapse.

Warnings and precautions:

Talk to your doctor, pharmacist, or nurse before starting to use Nippon Gases Liquid Medical Oxygen.

You must inform your doctor if you suffer from 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 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 concentration of inhaled oxygen. It is advisable, in any case, to 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 in the treatment of 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).
• When oxygen is administered under high pressure (hyperbaric oxygen therapy), injuries may occur in body cavities containing air and communicating with the outside; therefore, 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 pulmonary disorder caused by loss of elasticity of lung tissue, accompanied by severe respiratory 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 suffer from severe epilepsy.
  • You have 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.

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).

Other medicines and Nippon Gases Liquid Medical Oxygen

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.

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 Nippon Gases Liquid Medical Oxygen on driving and operating machinery.

3. How to use Nippon Gases Medicinal Liquid Oxygen

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

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

If you think that the effect of Nippon Gases Medicinal Liquid Oxygen is too strong or too weak, inform your doctor.

If you use more Nippon Gases Medicinal Liquid Oxygen 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 Liquid Oxygen Nippon Gases may cause adverse effects, although not everyone will experience them.

In particular, in chronic respiratory failure, there may be a risk of apnea.

Inhalation of high oxygen concentrations may cause minor lung collapse.

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

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

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

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

Other adverse effects in children

In newborns, especially if premature, exposed to high oxygen concentrations (FiO2 >40%; PaO2 above 80 mm Hg (i.e., 10.64 kPa)) or for prolonged periods (more than 10 days at FiO2 >30%), there is a risk of retinopathy, which may appear between 3 and 6 weeks after treatment. This condition may regress spontaneously or may 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 through 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 Nippon Gases Medicinal Liquid Oxygen

Keep this medicine out of 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 regarding the handling of pressurized containers must be followed.

The following considerations apply to storage and transportation:

Storage of containers:

Containers must be installed in well-ventilated areas. The installation site must be enclosed by a fence that can be locked, and the area must be kept clean and free of flammable materials.

Containers must be protected from sources of heat or ignition, temperatures equal to or above 50°C, as well as from combustible materials. Entry of water into the containers must be prevented.

Transportation of containers:

Do not park vehicles in the oxygen transfer area.

6. Contents of the pack and other information

Composition of Medicinal Liquid Oxygen Nippon Gases:

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

Appearance of the product and contents of the container

The containers are fixed stainless steel cryogenic vessels of various capacities.

The different sizes are indicated below, classified by their approximate capacity in liters of liquid oxygen and the gas content at a supply pressure of 1 bar at 15°C:

• Fixed cryogenic container 2200 liters provides 1870 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 3300 liters provides 2805 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 6100 liters provides 5185 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 11000 liters provides 9350 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 13400 liters provides 11390 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 17000 liters provides 14450 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 20000 liters provides 17000 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 28000 liters provides 23800 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 32000 liters provides 27200 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 37000 liters provides 31450 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 41000 liters provides 34850 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 50000 liters provides 42500 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 60000 liters provides 51000 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 230 liters provides 182 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 600 liters provides 500 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 600 liters provides 510 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 1000 liters provides 756 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 1500 liters provides 1156 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 2000 liters provides 1541 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 3000 liters provides 2250 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 5000 liters provides 4250 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 12700 liters provides 10795 m³ of gas at a pressure of 1 bar at 15°C
• Fixed cryogenic container 27000 liters provides 22950 m³ of gas at a pressure of 1 bar at 15°C
• Transportable fixed cryogenic container 13600 liters provides 12970 m³ of gas at a pressure of 1 bar at 15°C

Not all container sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

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

Manufacturer:

NIPPON GASES ESPAÑA S.L.U.
Madrid-Irun Road, Km. 418
20212 Olaberria (Guipúzcoa)
Spain

OR

NIPPON GASES ESPAÑA S.L.U.
Pasaje del Metal 14-15
Pol. Ind. San Vicente
08755 Castellbisbal (Barcelona)
Spain

OR

NIPPON GASES ESPAÑA S.L.U.
Gavilanes St., 12
Pol. Ind. La Estación
28320 Pinto (Madrid)
Spain

OR

NIPPON GASES ESPAÑA S.L.U.
Pol. Ind. Somonte II
33393 Gijón (Asturias)
Spain

OR

SE CARBUROS METÁLICOS S.A.
Aragón St., 300, 08009 Barcelona
Spain

OR

ANDALUZA DE GASES S.A (AGSA)
Hacienda de Dolores Industrial Estate, Seville-Málaga Road, km 6.3
41500 Alcalá de Guadaira, Seville
Spain

OR

GASES OXINORTE A.I.E
Buen Pastor St., s/n
48903 Baracaldo (Vizcaya)
Spain

OR

SOCIEDAD PORTUGUESA DE OXIGENIO, LDA (SPO)
Professor Antonio Marques St., 99. P.O. Box 1188 - Lugar de São Frutuoso-Folgosa
4425-390 Maia, Portugal

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

Detailed information on this medicine is available on the website of the Spanish Agency of Medicines and Medical Devices (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.

For liquid oxygen specifically, additional product characteristics must also be considered as precautions for its use and handling:

• Oxygen is a gas heavier than air, which may accumulate in low-lying areas after vaporization of the liquid and render the atmosphere hazardous.
• At atmospheric pressure, oxygen is a liquid at a very low temperature (around -183°C), and contact with skin may cause frostbite burns in case of splashing or handling the liquid without appropriate protective equipment.
• One liter of liquid oxygen releases 850 liters of gas upon vaporization and warming to room temperature. The expansion of liquid oxygen upon warming is 850 times its liquid volume; therefore, appropriate precautions must be taken against overpressure in closed volumes (equipment and installations) and against over-oxygenation of materials and the atmosphere in enclosed spaces.

Medicinal oxygen containers are reserved exclusively for therapeutic use.

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

• Never introduce this gas into any apparatus suspected of containing combustible materials, especially those of a greasy nature.
• Never clean apparatus containing this gas, or taps, gaskets, seals, closure devices, or valves with combustible 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.
• Check the equipment is in good condition before use.
• Handle the equipment with clean, grease-free hands.
• When handling cryogenic containers, use the specified personal protective equipment (goggles or face shields, clean gloves designated for this purpose, appropriate clothing, etc.) and follow the instructions and precautions described for the operation.
• Use oxygen-specific connections or flexible connection components.
• Use only equipment specifically approved for this product and for the intended pressure and temperature conditions.