Medicinal oxygen gas Linde medicinal compressed 99.5% v/v in cylinders

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

MEDICINAL OXYGEN GAS LINDE, compressed medicinal gas, 99.5% v/v, in cylinders

Medicinal 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, consult your doctor or pharmacist.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor or pharmacist, even if they are adverse effects not listed in this leaflet. See section 4.

Contents of the leaflet

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

1. What OXÍGENO MEDICINAL GAS LINDE is and what it is used for

OXÍGENO MEDICINAL GAS LINDE is an inhalation gas belonging to a group of medicines known as medicinal gases. It is supplied in pressurized cylinders containing pure oxygen only.

Oxygen is an essential element for the body and is administered to increase its levels in the blood, thereby achieving improved oxygen delivery to all body tissues.

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 anaesthetic and resuscitation ventilators.
• Administration of inhaled medications via nebuliser.

2. Before using OXÍGENO MEDICINAL GAS LINDE

Do not use OXÍGENO MEDICINAL GAS LINDE:

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, inform your doctor.

Take special care with OXÍGENO MEDICINAL GAS LINDE:

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

• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face due to the risk of ignition (see Section 6).

• Because it may be toxic to the lungs or nervous system depending on the concentration and duration of administration (see Section 3 and Section 6).

Precautions for use

• Oxygen must not be used in the presence of flammable materials: oils, lubricants, fabrics, wood, paper, plastic materials, etc. (see Section 6).

• When 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. To avoid risks, compression and decompression must be performed slowly (see Section 4).

• When undergoing high-pressure oxygen therapy (hyperbaric oxygen therapy), you must inform your doctor if you have:

• Chronic obstructive pulmonary disease (COPD)
• A lung disorder caused by loss of elasticity of lung tissue accompanied by severe breathing difficulty (pulmonary emphysema)
• Upper respiratory tract infections
• Recent middle ear surgery
• Thoracic surgery at any time in your life
• Uncontrolled high fever
• Severe epilepsy
• Fear of enclosed spaces (claustrophobia)
• A previous history of lung collapse: an accumulation of air or gas in the pleural cavity between the two lung membranes (pneumothorax)

Use in children

In newborns, especially premature infants, eye damage (retrolental fibroplasia) may occur with certain oxygen concentrations (see Section 4).

Use of other medicines and other forms of interaction

Inform your doctor or pharmacist if you are taking or have recently taken any other medicines, including those obtained without a prescription.

• The toxicity of oxygen may be increased if used concomitantly with other medicines that may also affect the lungs: corticosteroids, certain anticancer drugs (bleomycin), sympathomimetics. This may also occur during treatment for paraquat poisoning, when using X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione deficiency.
• There are reports of interaction with amiodarone. Recurrence of lung damage induced by bleomycin or actinomycin may be fatal.
• Oxygen may also worsen respiratory depression caused by alcohol.
• Among the medicines known to cause adverse effects are: adriamycin, menadione, promazine, chlorpromazine, thioridazine, and chloroquine. These effects will be particularly pronounced in tissues with high oxygen levels, especially the lungs.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

During pregnancy, oxygen use at normal pressure (normobaric oxygen therapy) is permitted at low concentrations.

In life-saving treatments, oxygen may also be used during pregnancy at high concentrations and high pressures.

There are no contraindications for using oxygen during breastfeeding periods.

Consult your doctor or pharmacist if you need advice before taking any medicine.

Driving and use of machines

There are no data on the effect of medicinal oxygen on driving and operating machinery; therefore, you may drive but should exercise extreme caution.

3. How to use OXIGENO MEDICINAL GAS LINDE

Follow exactly the oxygen administration instructions provided by your doctor.

OXIGENO MEDICINAL GAS LINDE is used by inhalation. Your doctor will determine the correct dose of medicinal oxygen and administer it through a system appropriate to your needs, ensuring delivery of the correct amount of oxygen.

Dosage. The usual dosage is:

• In patients who breathe spontaneously (spontaneous ventilation) with acute respiratory failure, oxygen is administered at a flow rate of 0.5 to 15 liters/minute. This may vary depending on test results (blood gas analysis).
• In patients who breathe spontaneously (spontaneous ventilation) with chronic respiratory failure, oxygen is administered at a flow rate of 0.5 to 2 liters/minute. This may vary depending on test results (blood gas analysis).
• In patients requiring breathing assistance (assisted ventilation), oxygen should be administered at a dose allowing achievement of a minimum oxygen concentration of 21%, up to 100%.

Method of administration

• In patients without ventilation problems: oxygen may be administered via spontaneous ventilation using nasal glasses, a nasopharyngeal catheter, or a mask, which must be adapted to the oxygen flow rate.

• In patients with ventilation problems, or who are anesthetized, oxygen is administered using special devices such as an endotracheal tube, laryngeal mask, through a tracheostomy allowing connection to assisted ventilation, or other devices.

• Administration of oxygen at high pressure (hyperbaric oxygen therapy) is performed in a hyperbaric chamber at a pressure of 2 to 3 atmospheres, with session durations ranging from 90 minutes to 2 hours. These sessions may be repeated 2 to 4 times daily, depending on clinical indications and the patient's condition.

Duration of treatment

As a general rule, high oxygen concentrations should be used for the shortest possible time needed to achieve the desired effect. The administered oxygen concentration should be reduced as soon as possible to the minimum necessary concentration.

• Oxygen concentrations up to 100% should not be administered for longer than 6 hours.
• Oxygen concentrations between 60–70% should not be administered for longer than 24 hours.
• Oxygen concentrations between 40–50% should not be administered continuously for the following 24 hours.
• Any oxygen concentration above 40% is potentially toxic after 2 days.

If you feel that the effect of OXIGENO MEDICINAL GAS LINDE is too strong or too weak, inform your doctor.

Read the instructions for use carefully (see Section 6).

If you use more OXIGENO MEDICINAL GAS LINDE than you should:

In certain situations, excessive oxygen may affect breathing and, rarely, cause anesthesia or unconsciousness due to carbon dioxide retention.

Oxygen toxicity effects vary depending on the pressure of inhaled oxygen and the duration of exposure.

At low pressure (0.5 to 2.0 bar), these effects are more likely to occur in the pulmonary region than in the central nervous system (brain and spinal cord). At high pressure (hyperbaric oxygen therapy), the opposite occurs.

Effects in the pulmonary region include interrupted breathing (hypoventilation), cough, and chest pain. Effects on the central nervous system range from nausea, dizziness, anxiety, and confusion to muscle spasms, loss of consciousness, and epileptic seizures.

If symptoms occur, contact your doctor or hospital, or call the Toxicology Information Service at telephone: 91 562 04 20.

In case of overdose, the appropriate action is to reduce the concentration of inhaled oxygen, and symptomatic treatment is recommended.

4. Possible adverse effects

Like all medicines, MEDICINAL OXYGEN GAS LINDE may cause adverse effects, although not everyone experiences them.

When oxygen is administered via nasal glasses, it may cause dryness of the nasal and labial mucous membranes.

Adverse effects usually occur when high oxygen concentrations (above 70%) are used and after prolonged treatment (at least 6–12 hours).

Uncommon adverse effects, which may affect between 1 and 10 out of 1,000 patients, are:

• Respiratory, thoracic and mediastinal disorders: atelectasis (collapse of pulmonary alveoli), dry cough and pain associated with breathing.

• With high-pressure oxygen (hyperbaric oxygen therapy): Ear and labyrinth disorders such as sensation of pressure in the middle ear and rupture of the tympanic membrane.

Rare adverse effects, which may affect between 1 and 10 out of 10,000 patients, are:

• Eye disorders: eye damage that may affect vision (retrolental fibroplasia) in premature newborns exposed to high oxygen concentrations.

Very rare adverse effects, which may affect fewer than 1 in 10,000 patients, are:

• Respiratory, thoracic and mediastinal disorders: severe difficulty in breathing due to acute lung failure (acute respiratory distress syndrome).

• With high-pressure oxygen (hyperbaric oxygen therapy): nervous system disorders such as anxiety, confusion, loss of consciousness, and epileptic seizures.

Other reported adverse effects with unknown frequency are:

• Apnea (cessation of breathing): in patients with chronic respiratory failure.
• Sinus injuries, pneumothorax (presence of air in the thoracic cavity), nausea, dizziness, temporary loss of vision, muscle pain and cramps with high-pressure oxygen (hyperbaric oxygen therapy).
• Claustrophobia attacks: in patients undergoing high-pressure oxygen treatment in hyperbaric chambers.
• Anaemia.
• Organ involvement with high oxygen concentrations during long-term treatment: heart (may also reduce heart rate when 100% oxygen is administered over short periods), liver, kidneys and lungs (pulmonary fibrosis).
• Pulmonary malformations (bronchopulmonary dysplasia), haemorrhages in various locations (subependymal and intraventricular), and intestinal damage with tissue destruction (necrotizing enterocolitis) in newborns and premature infants.

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effect not mentioned in this leaflet, inform your doctor.

5. Storage of MEDICINAL OXYGEN GAS LINDE

Keep MEDICINAL OXYGEN GAS LINDE out of the reach and sight of children.

All regulations concerning the handling of pressurized containers must be observed. The following considerations apply to storage and transport:

Storage of cylinders:

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

Empty and full cylinders must be stored separately.

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.

Cylinders with a capacity greater than 5 liters must be kept in an upright position (except those with a rounded base), with valves closed.

Storage of cylinders at user facilities and in domestic settings:

Cylinders must be installed in a location that protects them from impact or falling (e.g., using a stand with securing chains), as well as from 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. Particular attention must be paid to securing the pressure regulator to prevent accidental rupture.

During transport in vehicles, cylinders must be securely fastened, preferably in an upright position. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

Expiry date

Do not use MEDICINAL OXYGEN GAS LINDE after the expiry date stated on the container.

6. Additional Information

Composition of OXÍGENO MEDICINAL LÍQUIDO LINDE

• The active substance is Oxygen.
• No excipients.

Presentation of OXÍGENO MEDICINAL LÍQUIDO LINDE and contents of the container

OXÍGENO MEDICINAL LÍQUIDO LINDE is a cryogenic medicinal gas. Oxygen is a colorless, odorless, and tasteless gas. When liquefied, it has a slightly blue color.

It is stored in mobile cryogenic containers made of stainless steel.

The mobile cryogenic containers consist of a double-walled stainless steel construction.

These are supplied under pressure as a liquid at very low temperature (approximately -183°C) in thermally insulated vessels specifically designed for storing cryogenic liquids. Keep away from flames. Do not grease. Instructions for use / handling: Do not smoke. The capacities of the containers are 30 and 45 liters.

Marketing Authorization Holder

Linde Médica, S.L.U.

Camino de Liria, s/n, apartado de correos nº 25,

46530 Puzol, Valencia

Spain

Manufacturer

Abelló Linde, S.A. Polígono Industrial Can Pí de Vilaroch, Avda. Antonio Gaudí, 151, Rubí, 08191 Barcelona

S.E. DE CARBUROS METALICOS, S.A. Barrio Chaco s/n (Arrigorriaga (Vizcaya)) - 48480 - Spain
S.E. DE CARBUROS METALICOS, S.A. Crta. Sevilla a Granada, Km. 9,6. Pol. Ind. La Red (Alcalá de Guadaira (Sevilla)) - 41500 – Spain

S.E. DE CARBUROS METALICOS, S.A. Pol. Ind. Can Rubiol. Celleters, 142 (Marratxí (Islas Baleares)) - 07141 - Spain

S.E. DE CARBUROS METALICOS, S.A.

Avda. Madrid, 82.

Laguna de Duero (Valladolid)

Abelló Linde, S.A.

Camino de Lliria, s/n

Puçol (Valencia), 46530 – Valencia.

Abelló Linde, S.A.

Pol. Ind. El Bierzo, C/Hamburgo, 16.

Ponferrada, 24400 León.

Instructions for use / handling

Do not smoke

Keep away from 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 with combustible products, especially those of a greasy nature, either the equipment containing this gas or the valves, seals, gaskets, and closure devices.
• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosols (hairspray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

The containers of MEDICINAL OXYGEN are reserved exclusively for therapeutic use.

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 very low temperature (around -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, precautions against overpressure in closed volumes (equipment and installations) and against over-oxygenation of materials and the atmosphere in enclosed spaces must be taken.

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

1. Check the equipment is in good condition before use.
2. At the time of delivery by the manufacturer, verify that the container is equipped with an intact tamper-proof seal.
3. Handle the equipment with clean, grease-free hands.
4. Use protective goggles and clean gloves intended for this purpose.
5. Do not touch cold or frosted parts.
6. In case of cryogenic burn, rinse thoroughly with abundant water.
7. If clothing becomes saturated with oxygen, move away from the source of liquid oxygen and from areas with fire risk, and remove the clothing.
8. Ventilate the area of use if possible, especially in confined spaces (vehicles, homes).
9. Avoid exposure to heat sources or prolonged solar heating.
10. Open the valve gradually.
11. Close the container valve after use.
12. Never force any part of the container and do not attempt to repair a defective valve.
13. Never exceed the maximum service pressure.
14. Provide safety devices against overpressure in liquid oxygen circuits where there is a risk of liquid accumulation between two valves.
15. Store containers grouped together and in an upright position.
16. Use connections or flexible connecting elements specifically designed for oxygen.
17. Do not use intermediate connectors to connect two devices that do not fit together.
18. In case of leakage, close the valve with the leak and check that the emergency device activates. Do not use a leaking container.
19. Use only equipment specifically approved for this product and for the intended pressure and temperature of use.
20. Prevent backflow of substances into the container. Prevent water from entering the container.

This leaflet was last approved on:

This information is intended for healthcare professionals only:

Dosage depends on the patient's clinical condition. The oxygen dose must be adjusted according to the individual requirements of each patient, taking into account the risk of oxygen toxicity.

In any case, the goal of oxygen therapy is to maintain arterial partial pressure of oxygen (PaO₂) above 60 mm Hg (i.e., 7.96 kPa) or arterial oxygen saturation at or above 90%.

If oxygen is administered diluted in another gas, its minimum concentration in the inspired air must be 21%, i.e., the inspired fraction (FiO₂) must be 21%, up to a maximum concentration of 100%.

Warnings and precautions for use

• In certain severe cases of hypoxia, the therapeutic dose approaches the toxicity threshold. After 6 hours of exposure to 100% oxygen concentration, or after 24 hours of exposure to oxygen concentrations 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 concentration of inhaled oxygen. In all cases, the lowest effective dose should be used to maintain arterial partial pressure of oxygen (PaO₂) at 50–60 mm Hg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, oxygen concentration should be maintained, as far as possible, below 45%.

• In neonates and premature infants, the lowest possible concentration achieving the desired effect should be used to minimize the risk of ocular damage, retrolental fibroplasia, or other potential adverse effects. For infants requiring an oxygen concentration (FiO₂) above 30%, PaO₂ should be monitored regularly to ensure it does not exceed 100 mmHg (i.e., 13.3 kPa) due to the risk of retinal damage.

• Whenever oxygen is used, the increased risk of spontaneous ignition and fire must always be considered. This risk is increased during procedures involving diathermy, defibrillation, and electroconvulsive therapy.