Conoxia 99,5% (v/v) gas criogenico medicinal

Leaflet: information for the user

Cryogenic medicinal gas Conoxia 99.5% (v/v)

Oxygen

Read this leaflet carefully before you start using 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 others even if they have the same symptoms as you, as it may harm them.

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

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

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

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

4. Possible side effects

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

6. Contents of the pack and additional information

Conoxia 99.5% (v/v) medical cryogenic gas is an inhalation gas that is supplied in a conditioned liquid state in cryogenic containers at cryogenic temperature (approx. -183°C).

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

It does not contain other excipients..

Oxygen is an essential element for the body. Oxygen treatment is indicated in the following cases:

followed by:

• Correction of oxygen deficiency of different origins that require oxygen administration at normal or elevated pressure.
• Supply of respirators in anesthesia - resuscitation.
• Administration via nebulizer of inhalation medications.

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

This medicine 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.

Inform your doctor if you have had a pulmonary collapse previously.

Warnings and precautions

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

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 fatty substances (vaseline, ointments, etc.) 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 greater than 70%, pulmonary or neurological toxicity may appear (see sections 3 and 6). Therefore, important concentrations must be used for the shortest possible time and controlled by analysis of arterial blood gases, at the same time as the concentration of inhaled Oxygen is measured.

It is advisable to use, in any case, the smallest dose capable of maintaining the partial pressure of arterial Oxygen (PaO2) at 50-60 mmHg (i.e., 5.65-7.96 kPa) and, after 24 hours of exposure, to try to maintain, as far as possible, a concentration of Oxygen below 45%.

Precautions for use

- This medicine must 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, compression and decompression must be slow. (see section 4).

- If you are going to receive high-pressure Oxygen therapy (hyperbaric Oxygen therapy), you must inform your doctor of any of the following situations:

- If you have Chronic Obstructive Pulmonary Disease (COPD).

- If you have a pulmonary alteration caused by the loss of elasticity of the pulmonary tissue accompanied by severe respiratory difficulty (pulmonary emphysema).

- If you have any upper respiratory tract infection (e.g. bronchitis).

- If you have chronic bronchitis.

- If you have recently undergone middle ear surgery.

- If you have had thoracic surgery at any time in your life.

- If you have high and uncontrolled fever.

- If you have severe epilepsy.

- If you have claustrophobia.

- If you have had a pulmonary collapse previously (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 (alterations in the retina) may occur with certain Oxygen concentrations.

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

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

Inform your doctor or pharmacist if you are using, have used recently, 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 vitamin C and E deficiency or glutathione deficiency.

Pregnancy and breastfeeding

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

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

Driving and operating machinery

There are no data on the effect of Conoxia 99.5% (v/v) medical cryogenic gas on driving and operating machinery.

Follow exactly the administration instructions for this medication 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) medical cryogenic gas and willadminister it through an appropriate system for your needs that will ensure the supply of thecorrect amount of Oxygen.

If you estimate that the action of Conoxia 99.5% (v/v) medical cryogenic gas is too strong or weak,inform your doctor.

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

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

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

Like all medications, Conoxia 99.5% (v/v) cryogenic gas may produce adverse effects, although not all people will experience them.

In particular, chronic respiratory insufficiency may lead to the possibility of apnea. High oxygen concentrations may cause small lung collapses upon inhalation.

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

Seizures have been registered after administration of 100% oxygen for more than 6 hours, particularly with high-pressure administration.

Pulmonary injuries may occur after administration of oxygen concentrations above 80%.

In newborns, particularly premature ones, exposed to strong oxygen concentrations (FiO2 > 40%; PaO2 above 80 mmHg, i.e., 10.64 kPa), or for an extended period (more than 10 days at a FiO2 concentration > 30%), there is a risk of retinopathies, which appear between 3 and 6 weeks after treatment, potentially experiencing regression or causing retinal detachment, or even permanent blindness.

Patients subjected to high oxygen pressures in chambers may experience claustrophobia crises.

If you experience adverse effects, consult your doctor, pharmacist, or nurse, even if they do not appear in this prospectus.

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

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

All guidelines related to the handling of pressure vessels must be followed. In relation to storage and transportation, the following must be taken into account:

Storage of Cryogenic Containers:

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

Appropriate precautions must be taken to avoid shocks, impacts, or falls.

Empty and full containers must be stored separately.

Storage of Containers at Home:

Containers must be installed in a location that protects them from the risks of impacts and falls, heat sources or ignition, temperatures equal to or greater than 50°C, combustible materials, and inclement weather.

Excessive storage must be avoided.

Transportation of Containers:

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

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

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

- The active principle is: Oxygen (O2) in a concentration of 99.5% (v/v) or greater.

- It does not contain excipients.

Aspect of the product and contents of the packaging

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

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

The different presentations are:

-Domestic cryogenic containers:21 liters, 31 liters, 41 liters.

- Mobile cryogenic containers:160 liters, 210 liters, and 600 liters.

- Cisterns:7,000 liters, 10,000 liters, 12,100 liters, 17,500 liters, 21,000 liters, 22,000 liters, 23,000 liters, and 23,500 liters.

Not all packaging sizes may be commercially available.

Holder of the marketing authorization:

Linde GAS ESPAÑA, S.A.U.

C/ Camino de Liria, s/n,

apartado de correos number 25,

Puzol, 46530 Valencia, Spain

Responsible for manufacturing:

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 review of this prospectus:June 2009.

The detailed information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es.

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

Instructions for use/manipulation

Do not smoke.

Do not bring near a flame.

Do not lubricate.

Specifically:

- Do not introduce this gas into an apparatus that is suspected to contain combustible materials, especially if they are greasy in nature.

- Do not clean with combustible products, especially if they are greasy in nature, or the apparatus containing this gas, or the valves, or the joints, or the seals, or the closure devices.

- Do not apply any greasy substance (vaseline, ointments, etc.) to the patients' faces.

- Do not use aerosols (lacquer, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

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

1. Verify the good condition of the material before its 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 burn, rinse with plenty of water.

6. If the clothing becomes saturated with Oxygen, move away from the Oxygen liquid source and from areas that may pose a risk of inflammation, and remove this clothing.

7. Ventilate, if possible, the area of use, if it is a reduced location (vehicles, home).

8. Open the cryogenic container valve gradually.

9. Never exceed the maximum service pressure.

10. Use specific regulators for Oxygen.

11. Do not use intermediate regulators that allow connecting two devices that do not fit.

12. Do not subject the flexible hose to a too small curvature radius. Do not leave the flexible hose on the floor. 13. Provide safety devices against overpressure in Oxygen liquid circuits where there is a risk of accumulating liquid between two valves.

14. In case of a leak, close the valve with a defect in tightness and check that the emergency device is activated.