Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank

Oxygen

Read the entire leaflet carefully before starting to take/use this medicine, as 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, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you must 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, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet

1. What Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank is and what it is used for
2. What you need to know before using Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank
3. How to use Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank
4. Possible adverse effects
5. How to store Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank
6. Contents of the pack and other information

1. What Conoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank is and what it is used for

Conoxia 99.5% (v/v) medicinal cryogenic gas in a fixed tank is an inhalation gas supplied
in liquid form, stored in fixed cryogenic containers at cryogenic temperature (approximately -183°C).

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

It contains no 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 inhalation medications.

2. What you need to know before using Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank

Oxygen conditioned in cryogenic containers is a liquid at cryogenic temperature (approx. -183°C); therefore, contact with the skin may cause severe frostbite (see section Additional Information).

In case of frostbite, rinse with room temperature water for 15 minutes. Apply a sterile dressing and seek medical assistance. In case of eye contact, immediately rinse eyes with room temperature water for at least 15 minutes and seek medical assistance.

Do not use Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank:

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.

Inform your doctor if you have previously suffered a lung collapse.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Conoxia 99.5% (v/v) medicinal cryogenic gas.

You must inform your doctor if you have chronic lung disease such as bronchitis, emphysema, or asthma, and in severe situations 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 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, in any case, the lowest dose sufficient to maintain arterial partial pressure of oxygen (PaO2) at 50–60 mmHg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, it is recommended, as far as possible, to maintain an oxygen concentration below 45%.

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 high-pressure oxygen is administered (hyperbaric oxygen therapy), injuries may occur due to high pressure in body cavities containing air that communicate with the outside. 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 lung tissue elasticity accompanied by severe respiratory difficulty (pulmonary emphysema).
• You have an infection in the upper respiratory tract (e.g., bronchitis).
• You have chronic bronchitis.
• You have recently undergone middle ear surgery.
• You have previously undergone thoracic surgery.
• You have uncontrolled high fever.
• You have severe epilepsy.
• You have fear of enclosed spaces (claustrophobia).
• You have previously suffered 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 (retinal abnormalities) 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 mmHg (i.e., 13.3 kPa).

Use of Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank with other medicines

Inform your doctor or pharmacist if you are currently 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 and breastfeeding

If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, consult your doctor or pharmacist before using this medicine.

Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank has been widely used without any notable adverse effects.

Driving and use of machines

There are no data available on the effects of Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank on driving and operating machinery.

3. How to use Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank

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

Your doctor will determine the correct dose of Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank and will administer it to you through a system suitable for your needs, ensuring the delivery of the correct amount of Oxygen.

If you feel that the effect of Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank is too strong or too weak, inform your doctor.

If you use more Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank than you should:

In case of overdose, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount inhaled.

In case of overdose, the concentration of inhaled Oxygen should be reduced and symptomatic treatment is recommended.

4. Possible adverse effects

Like all medicines, Conoxia 99.5% (v/v) cryogenic gas in fixed tank 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 small lung collapses.

Administration of Oxygen at high pressures may cause injury to the inner ear (potentially risking rupture of the tympanic membrane), the nasal sinuses, and the lungs (potentially risking pneumothorax).

Seizure episodes have been reported after administration of 100% Oxygen for more than 6 hours, particularly when administered at high pressure.

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

In newborns, especially if premature, exposure to high Oxygen concentrations (FiO2 > 40%; PaO2 > 80 mmHg (i.e., 10.64 kPa)), or prolonged exposure (more than 10 days at FiO2 > 30%), carries a risk of retinopathy, appearing between 3 and 6 weeks after treatment, which may either regress or lead to retinal detachment or even permanent blindness.

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

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

5. Storage of Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank

Keep this medicine out of the sight and reach of children.

All regulations concerning the handling of pressure vessels must be observed. The following points must be taken into account regarding storage and transport:

Storage of fixed cryogenic containers:

• Fixed cryogenic containers must be installed in clean, well-ventilated areas, free from flammable materials.
• Storage of gases intended for medical use must be separated from gases intended for other purposes.
• Fixed cryogenic containers must be protected from sources of ignition, heat, combustible materials, and even from static discharges.
• Fixed cryogenic containers must be protected from risks of impact, shocks, or falls.
• No parking must be allowed in the area where fixed cryogenic containers are located.

6. Contents of the container and additional information

Composition of Conoxia 99.5% (v/v) medicinal cryogenic gas in fixed tank

• The active substance is: Oxygen (O₂) at a concentration greater than or equal to 99.5% (v/v).
• It does not contain excipients.

Appearance of the product and contents of the container

Conoxia 99.5% (v/v) medicinal cryogenic gas is a gas for inhalation.

Oxygen stored in fixed cryogenic containers is a liquid at cryogenic temperature (approx. -183°C). The table shows the geometric capacity in liters and its corresponding volume in m³ of gas at 1 bar and 15°C. One liter of liquid oxygen provides approximately 850 liters of gaseous oxygen under conditions of 1 bar and 15°C.

Not all package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

LINDE GAS ESPAÑA, S.A.U.
Camino de Liria, s/n,
46530 Puzol, Valencia, Spain. Telephone: 93.476.74.00

Date of most recent review of this leaflet: June 2009

Detailed and up-to-date information on this medicinal product 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 a flame.
Do not grease.

Handling of cryogenic containers:

For liquid oxygen specifically, additional product-specific 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, creating a hazardous atmosphere.
• The contents of fixed cryogenic containers consist of oxygen in liquid form at atmospheric pressure and very low temperature (approximately -183°C), which 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 to prevent overpressure in closed volumes (equipment and installations) and over-oxygenation of materials and the atmosphere in enclosed spaces.

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

1. Never introduce the gas into a device suspected of containing combustible materials, especially those of a greasy nature.

2. Never clean devices containing this gas, nor valves, seals, gaskets, or closure devices, with combustible products, especially those of a greasy nature.

3. Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face.

4. Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

5. Check the equipment is in good condition before use.

6. Handle the equipment with clean, grease-free hands.

7. When handling cryogenic containers, use the indicated 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.

8. Do not touch cold or frosted parts.

9. In case of cryogenic burn, rinse thoroughly with abundant water.

10. If clothing becomes saturated with oxygen, move away from the source of liquid oxygen and from areas presenting a risk of ignition, and remove the clothing immediately.

11. Ventilate the area of use if possible, especially in confined spaces (vehicles, homes).

12. Use only equipment specifically approved for Medical Oxygen and for the required pressures and temperatures of use.

13. Never exceed the maximum service pressure.

14. Provide safety devices against overpressure in liquid oxygen circuits where there is a risk of liquid accumulating between two valves.

15. In case of leakage, close the valve exhibiting the leak and verify that the emergency device is activated.