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

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

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

Oxygen

Read 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, because it could harm them.
• If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if such adverse effects are not listed in this leaflet.

Leaflet contents

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

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

3. How to use Nippon Gases Medicinal Liquid Oxygen.

4. Possible side effects.

5. How to store Nippon Gases Medicinal Liquid Oxygen.

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, medicinal cryogenic gas, is an inhalation gas supplied in portable cryogenic containers made of stainless steel with various capacities.

It contains oxygen at a concentration higher 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-reanimation ventilators.
• Administration via nebulizer of inhalation 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 líquido Nippon Gases

Do not use Oxígeno Medicinal líquido Nippon Gases

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 pleural membranes. If you have previously experienced a lung collapse.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Oxígeno Medicinal Líquido Nippon Gases.

You must inform your doctor if you have a chronic lung disease such as bronchitis, emphysema, or asthma, and in severe cases 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 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 time and monitored by arterial blood gas analysis, while simultaneously measuring the concentration of inhaled oxygen. It is advisable to 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 used in 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).
• If oxygen is administered under high pressure (hyperbaric oxygen therapy), injuries may occur due to pressure changes in body cavities containing air that communicate with the outside. Compression and decompression must therefore 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 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 pleural membranes (pneumothorax)).

Children

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

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 Oxígeno Medicinal Líquido 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 anticancer drugs, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione deficiency.

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, 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 use of machines

There are no data available on the effects of Oxígeno Medicinal Líquido Nippon Gases on driving and operating machinery.

3. How to use Nippon Gases Liquid Medical Oxygen

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

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

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

If you use more Nippon Gases Liquid Medical 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 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, Medicinal Liquid Oxygen Nippon Gases may cause 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 minor collapses in the lung.

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

Seizure episodes have been reported following 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 episodes of claustrophobia.

Other adverse effects in children

In newborns, particularly 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 an FiO2 concentration >30%), there is a risk of retinopathy, which may appear between 3 and 6 weeks after treatment. This condition may regress 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 Medical Liquid Oxygen

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 pressure vessels must be followed.

The following considerations apply to storage and transport:

Storage of containers:

Containers must be stored in well-ventilated or ventilated areas, 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 containers must be stored separately.

Containers must be protected against impact or falling, as well as against sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions. They must be kept in an upright position with valves closed.

Storage of containers at user facilities and in domestic settings:

The container must be installed in a location that ensures its protection in an upright position against risks of impact or falling (such as a support with securing elements), sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, adverse weather conditions, and heat sources that could cause gasification.

Excessive storage must be avoided.

Transport of containers:

Do not park vehicles in oxygen transfer areas.

Containers must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling and to maintain them in an upright position. During transport in vehicles, containers 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 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 portable cryogenic vessels made of stainless steel with various capacities.

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

• Stationary Unit UE30, approximately 30 liters with vaporizer, provides 25.50 m³ of gas.
• Stationary Unit UE31, approximately 29 liters with vaporizer, provides 24.95 m³ of gas.
• Stationary Unit UE41, approximately 39 liters with vaporizer, provides 33.50 m³ of gas.
• Stationary Unit UE45, approximately 45 liters with vaporizer, provides 38.25 m³ of gas.
• Stationary Unit UE46, approximately 45 liters with vaporizer, provides 37.92 m³ of gas.
• Stationary Unit UE60, approximately 58 liters with vaporizer, provides 49.30 m³ of gas.
• Cryogenic cylinder PGS45, approximately 147 liters with vaporizer, provides 125 m³ of gas.
• Cryogenic cylinder PGS180, approximately 165 liters with vaporizer, provides 140 m³ of gas.
• Cryogenic cylinder PGS240, approximately 200 liters with vaporizer, provides 170 m³ of gas.
• Cryogenic cylinder EaseBulk 600, approximately 600 liters with vaporizer, provides 510 m³ of gas.
• Pallet Tank PT666, approximately 626 liters with vaporizer, provides 532 m³ of gas.

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.
Barrio de Occidente, S/N
14005- Córdoba
Spain

OR

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

OR

NIPPON GASES ESPAÑA S.L.U
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 latest revision of this leaflet: July 2015

Detailed information on this medicine 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 a 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 (approximately -183°C), and may cause frostbite if it comes into contact with the skin due to 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 avoid any incidents, the following instructions must be strictly observed:

• Never introduce this gas into a device suspected of containing combustible materials, especially those of a greasy nature.
• Never clean with combustible products, particularly greasy substances, either the devices containing this gas or taps, seals, packings, closure devices, or valves.
• Do not apply any greasy substances (e.g., 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.
• Avoid exposure to heat sources (stoves, radiators, fireplaces, etc.) or prolonged solar heating.
• Ventilate the area of use if possible, especially in confined spaces (vehicles, homes).
• Check the equipment is in good condition before use.
• At the time of delivery by the manufacturer, verify that the container is equipped with an intact tamper-proof seal.
• Handle the equipment with clean, grease-free hands.
• For 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.
• Group containers together and keep them in an upright position.
• Use connections or flexible connecting elements specifically designed for oxygen.
• Use only equipment specifically approved for this product and for the intended pressure and temperature conditions.
• Provide safety devices against overpressure in each circuit section where residual liquid oxygen may remain trapped between two valves.
• Never touch cold or frozen parts of the equipment.
• Do not use intermediate adapters to connect two devices that do not fit together.
• Small cryogenic containers (Stationary Units) or their auxiliary equipment (Portable Units or backpacks) may have attached usage accessories (humidifier bottle, flowmeter, mask or nasal glasses, etc.). These devices must be used according to the prescribed conditions (flow rates, dosages, etc.).
• Open valves slowly and close them when the product is not in use.
• Never force any part of the cryogenic container or attempt to repair defective valves; in case of problems, contact the supplier.
• Never use a container that is leaking.
• If clothing becomes saturated with oxygen, move away from the liquid oxygen source and from areas with fire hazards. Remove the clothing as well.
• In case of cryogenic burn, rinse thoroughly with water.
• Prevent backflow of substances into the container. Water ingress into the container must be prevented.

Do not leave the equipment valve open when not in use.