CONOXIA 99.5% (v/v) MEDICINAL CRYOGENIC GAS

2. What you need to know before starting to use Conoxia 99.5% (v/v) cryogenic medicinal gas

Do not use Conoxia 99.5% (v/v) cryogenic medicinal gas

This medication cannot be used at high pressure in cases of untreated pulmonary collapses (untreated pneumothorax). A pulmonary collapse is an accumulation of gas in the thoracic cavity between the two pulmonary membranes.

Tell your doctor if you have had a pulmonary collapse in the past.

Warnings and precautions

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

You should inform your doctor if you have a chronic pulmonary disease such as bronchitis, emphysema, or asthma, and in severe cases of oxygen deficiency.

No fatty substances (vaseline, ointments, etc.) should be applied to the face, due to the risk of inflammation of this medication (see section 6).

In certain severe cases of oxygen deficiency, after 6 hours of exposure to a concentration of Oxygen of 100%, or after 24 hours of exposure to a concentration of Oxygen higher than 70%, pulmonary or neurological toxicity may occur (see sections 3 and 6). Therefore, high concentrations should be used for as short a time as possible and controlled by analyzing the gases in arterial blood, while measuring the concentration of inhaled Oxygen.

It is advisable to use the lowest effective dose to maintain the arterial partial pressure of Oxygen (PaO2) at 50-60 mmHg (i.e., 5.65-7.96 kPa) and, after 24 hours of exposure, to maintain, as far as possible, an Oxygen concentration below 45%.

Precautions for use

• This medication should not be used in the presence of flammable materials: oils, lubricants, tissues, wood, paper, plastic materials (see section 6).
• If oxygen is applied at high pressure (hyperbaric oxygen therapy), there may be injuries caused by the high pressure in the body cavities that contain air and are in communication with the outside, and compression and decompression should be slow (see section 4).
• If you are going to receive hyperbaric oxygen therapy, you should inform your doctor of any of the following situations:

• If you have COPD (chronic obstructive pulmonary disease).
• If you have a pulmonary disorder caused by the loss of elasticity of the lung tissue accompanied by severe respiratory difficulty (pulmonary emphysema).
• If you have an infection in the upper respiratory tract (e.g., bronchitis).
• If you have chronic bronchitis.
• If you have recently undergone middle ear surgery.
• If you have undergone thoracic surgery at any point in your life.
• If you have a high and uncontrolled fever.
• If you have severe epilepsy.
• If you have a fear of enclosed spaces (claustrophobia).
• If you have had a pulmonary collapse in the past (accumulation of air or gas in the thoracic cavity between the two pulmonary membranes (pneumothorax).

Children

In newborns, especially if they are premature, eye damage (retinal alterations) may occur with certain concentrations of oxygen.

In infants who need a concentration higher than 30%, the arterial partial pressure of Oxygen (PaO2) should be regularly controlled to not exceed 100 mmHg (i.e., 13.3 kPa).

Use of Conoxia 99.5% (v/v) cryogenic medicinal gas with other medications

Tell your doctor or pharmacist if you are using, have recently used, or may need to use any other medication.

The toxicity of Oxygen may be increased by: corticosteroids, some cancer medications, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione.

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 medication.

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

Driving and using machines

There are no data on the effect of Conoxia 99.5% (v/v) cryogenic medicinal gas on driving and using machines.

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

Follow the administration instructions of this medication exactly as indicated by your doctor. In case of doubt, consult your doctor again.

Your doctor will determine the correct dose of Conoxia 99.5% (v/v) cryogenic medicinal gas and administer it using a system suitable for your needs, ensuring the supply of the correct amount of Oxygen.

If you think the effect of Conoxia 99.5% (v/v) cryogenic medicinal gas is too strong or too weak, tell your doctor.

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

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

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

4. Possible side effects

Like all medications, Conoxia 99.5% (v/v) cryogenic medicinal gas may cause side effects, although not everyone will experience them.

In chronic respiratory failure, in particular, there is a possibility of apnea. 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 (which may pose a risk of rupture of the eardrum), the nasal sinuses, and the lungs (which may pose a risk of pneumothorax).

Seizures have been reported after administration of Oxygen with a concentration of 100% for more than 6 hours, particularly with administration at high pressure.

Pulmonary injuries may occur after administration of Oxygen concentrations higher than 80%.

In newborns, especially if they are premature, exposed to high concentrations of Oxygen (FiO2 > 40%; PaO2 higher than 80 mmHg, i.e., 10.64 kPa), or for a prolonged period (more than 10 days at a concentration FiO2 > 30%), there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, and may experience regression or cause retinal detachment, or even permanent blindness.

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

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

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

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

Do not use this medication after the expiration date shown on the label after {CAD}. The expiration date is the last day of the month indicated.

All regulations regarding the handling of pressure vessels must be followed. With regard to storage and transportation, the following must be taken into account:

Storage of cryogenic containers:

Liquid containers must be stored dry and clean in a covered area, protected from atmospheric agents and wind, and dedicated to the storage of medicinal gases. They must also be protected from heat sources or ignition, temperatures equal to or higher than 50°C, and combustible materials.

Precautions must be taken to avoid shocks, blows, or falls.

Empty and full containers must be stored separately.

Storage of containers at home:

Containers must be installed in a location that allows protection from the risks of blows and falls, heat sources or ignition, temperatures equal to or higher than 50°C, combustible materials, and weather conditions.

Excessive storage should be avoided.

Transportation of containers:

Containers must be transported with the help of suitable material to protect them from the risk of blows or falls.

During transportation in vehicles, containers must be well secured. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

6. Package contents and additional information

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

• The active ingredient is: Oxygen (O2) in a concentration of 99.5% (v/v) or higher.
• It does not contain excipients.

Appearance of the product and package contents

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

It is supplied in liquid form in cryogenic containers of different capacities or in tanks.

The different presentations are:

• Home cryogenic containers: 21 liters, 31 liters, 41 liters.
• Portable cryogenic containers: 160 liters, 210 liters, and 600 liters.
• Tanks: 7000 liters, 10000 liters, 12100 liters, 17500 liters, 21000 liters, 22000 liters, 23000 liters, and 23500 liters.

Not all pack sizes may be marketed.

Marketing authorization holder:

Linde GAS ESPAÑA, S.A.U.

C/ Camino de Liria, s/n,

post office box 25,

Puzol, 46530 Valencia, Spain

Manufacturer:

LINDE GAS ESPAÑA, S.A.U.

P.I. Bañuelos, C/ Haití, 1; Alcalá de Henares (Madrid) – 28806 – Spain.

or

LINDE GAS ESPAÑA, S.A.U.

P.I. Can Pí de Vilaroch., Avd. Antonio Gaudí, 151; Rubí (Barcelona) – 08191- Spain.

or

LINDE GAS ESPAÑA, S.A.U.

C/ Camino de Liria, s/n, Puzol – 46530, Valencia, Spain.

or

LINDE GAS ESPAÑA, S.A.U.

Políono Industrial Ciudad de Transporte P-27.1 A 27.4, Jerez de la Frontera, 11407 Cádiz, Spain.

or

OXIGENO DE SAGUNTO, S.L.

Parque Industrial de Sagunto, Esq NE, Parcela AMS, C/ Acería s/n

46520 Puerto de Sagunto (Valencia), Spain

or

LINDE PORTUGAL, LDA

Loteamento Vilar do Senhor, Unidade J

Vila Nova da Telha, Portugal

or

Linde GAS ESPAÑA , S.A.U.

C/Hamburgo, 16, Pol El Bierzo

24400 Ponferrada, Spain

or

MESSER IBERICA DE GASES, S.A.

Polígono Industrial El Morell s/n, El Morell, Tarragona 43760, Spain.

or

Linde GAS ESPAÑA , S.A.U.

C/ Pico Ocejón, 40; Torija 19190, Guadalajara, Spain.

Date of the last revision of this leaflet:June 2009.

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es.

--------------------------------------------------------------------------------------------------------------------This information is intended only for healthcare professionals:

Instructions for use/handling

Do not smoke.

Do not approach a flame.

Do not grease.

In particular:

• Never introduce this gas into a device that is suspected to contain combustible materials, especially if they are greasy.
• Never clean the devices that contain this gas, the valves, the gaskets, the seals, or the closing devices with combustible products, especially if they are greasy.
• Do not apply any greasy substances (vaseline, ointments, etc.) to the face of patients.
• Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

To avoid any incidents, it is necessary to strictly follow the following instructions:

1. Check the good condition of the material before use.
2. Handle the material with clean and grease-free hands.
3. Use protective glasses and clean gloves intended for this use.
4. Do not touch the cold or frosty parts.
5. In case of cryogenic burns, rinse with plenty of water.
6. If clothing becomes saturated with Oxygen, move away from the Oxygen liquid source and areas that pose a risk of inflammation, and remove the clothing.
7. Ventilate, if possible, the place of use, if it is a reduced location (vehicles, home).
8. Open the valve of the cryogenic containers progressively.
9. Never exceed the maximum service pressure.
10. Use specific fittings for Oxygen.
11. Do not use intermediate fittings that allow connecting two devices that do not fit.
12. Do not subject the flexible tube to a radius of curvature that is too small. Do not leave the flexible tube on the floor.
13. Provide safety devices against overpressure in Oxygen liquid circuits where there is a risk of liquid accumulation between two valves.
14. In case of leakage, close the valve that has a leak and check that the emergency device is activated.