CONOXIA GAS MEDICINAL COMPRESSED TABLET

Introduction

Package Leaflet: Information for the User

CONOXIA, compressed medical gas

Medical Oxygen 99.5% (v/v)

Read all of this leaflet carefully before you start using this medicine.

Keep this leaflet, you may need to read it again. If you have any further questions, ask your doctor or pharmacist.

This medicine has been prescribed for you, do not pass it on to others. It may harm them, even if their symptoms are the same as yours.

If you experience any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet.

Contents of the pack

1. What CONOXIA is and what it is used for
2. Before using CONOXIA
3. How to use CONOXIA
4. Possible side effects
5. Storage of CONOXIA
6. Further information

1. What CONOXIA is and what it is used for

CONOXIAis an inhalation gas that belongs to a group of medicines called medical gases. It is packaged in pressure bottles that contain only pure oxygen.

Oxygen is an essential element for the body and is administered to increase its levels in the blood and, as a result, achieve greater oxygen transport to all body tissues.

Treatment with oxygen is indicated in the following cases:

• Correction of oxygen deficiency from various sources that require the administration of oxygen at normal or high pressure.
• Feeding respirators in anesthesia - resuscitation.
• Administration of inhalation medications via a nebulizer.
• Treatment of acute phases of Cluster Headaches (Cluster Headache or Headache in Clusters).

2. Before using CONOXIA

Do not useCONOXIA:

There are no absolute contraindications for administering oxygen when its use is necessary.

Be careful withCONOXIA:

- If you have a chronic lung disease such as bronchitis, emphysema, or asthma, and in severe cases of oxygen deficiency. You should inform your doctor about this.

- Because it can be toxic to the lungs or nervous system depending on the concentration and duration of application (see Section 3 and Section 6).

Precautions for use

- No fatty substances (vaseline, ointments, etc.) should be applied to the face of patients due to the risk of inflammation (see Section 6).

- Oxygen 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 body cavities that contain air and are in communication with the outside. To avoid risks, compression and decompression should be slow (see Section 4).

Use in children

In newborns, especially if they are premature, there may be eye damage (retrolental fibroplasia) with certain concentrations of oxygen (see Section 4).

Use of other medicines and other forms of interaction

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

The toxicity of CONOXIAmay be increased if used at the same time as other medicines that also have an effect on the lungs: corticosteroids, some cancer medications (bleomycin), sympathomimetics. It can also occur when using paraquat, X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione.

Pregnancy and breastfeeding

It has been widely used without any notable effects.

Driving and using machines

There is no data on the effect of medical oxygen on driving and using machines, so you can drive but with extreme caution.

3. How to use CONOXIA

Follow the instructions for oxygen administration indicated by your doctor exactly.

CONOXIAis used by inhalation.

Your doctor will determine the correct dose of medical oxygen and administer it through a system suitable for your needs, ensuring the supply of the correct amount of oxygen.

Dosage. The usual dose is:

• In patients who breathe spontaneously (spontaneous ventilation) and have acute respiratory failure, oxygen is administered at a flow rate of 0.5 to 15 liters/minute. This may vary depending on the results of the analyzes performed (gasometry).
• In patients who breathe spontaneously (spontaneous ventilation) and have chronic respiratory failure, oxygen is administered at a flow rate of 0.5 to 2 liters/minute. This may vary depending on the results of the analyzes performed (gasometry).
• In patients with acute phases of Cluster Headache (Cluster Headache), oxygen administration should be performed as soon as possible after the start of the acute phase, at a flow rate of between 7 and 15 liters/minute, and for 15 minutes or until the disappearance of pain. Normally, a flow rate of between 7 and 10 liters/minute is sufficient, however, in some patients, it may be necessary to increase it up to 15 liters/minute to find effectiveness. Oxygen administration should be stopped if no effect is found after 15 or 20 minutes.
• In patients who require help breathing (assisted ventilation), oxygen should be administered at a dose that allows achieving a minimum oxygen concentration of 21%, which can reach up to 100%.

Method of administration

- In patients who do not have ventilation problems: oxygen can be administered by spontaneous ventilation with the help of nasal glasses, a nasopharyngeal tube, or a mask, which should be adapted to the oxygen flow.

- In patients who have ventilation problems or are anesthetized, oxygen is administered through special devices such as an endotracheal tube, laryngeal mask, through a tracheotomy that allows connection to assisted ventilation, or others.

- In the treatment of Cluster Headache, oxygen should be administered with a mask in a system without gas recirculation.

- The administration of oxygen at high pressure (hyperbaric oxygen therapy) is performed in a hyperbaric chamber at a pressure of 2 to 3 atmospheres, and the duration of the sessions is between 90 minutes and 2 hours. These sessions can be repeated between 2 and 4 times a day, depending on the indications and the patient's clinical condition.

Duration of treatment

As a general rule, high concentrations of oxygen should be used for the shortest possible time that allows achieving the desired result. The oxygen concentration administered should be reduced as soon as possible to the minimum concentration necessary.

• Concentrations of oxygen up to 100% should not be given for more than 6 hours.
• Concentrations of oxygen between 60-70% should not be given for more than 24 hours.
• Concentrations of oxygen between 40-50% should not be given for the following 24 hours.
• Any oxygen concentration above 40% is potentially toxic after 2 days.

If you think that the effect of CONOXIA is too strong or too weak, tell your doctor. Read the instructions for use carefully (see Section 6).

If you use moreCONOXIAthan you should:

In case of excessive use of oxygen, the inhaled oxygen concentration should be decreased, and symptomatic treatment is recommended.

Prolonged use of too much oxygen can cause pain, dry cough, and difficulty breathing.

In some situations, too much oxygen can affect breathing and exceptionally cause anesthesia or loss of consciousness due to carbon dioxide.

In case of overdose or accidental ingestion, consult your doctor immediately.

Consult the Toxicology Information Service (Telephone 91 562 04 20), indicating the product and the amount ingested.

4. Possible side effects

Like all medicines, CONOXIAcan cause side effects, although not everyone gets them. When oxygen is administered through nasal glasses, it can cause dryness of the nasal and labial mucosa.

Side effects usually appear when high concentrations of oxygen (above 70%) are used and after prolonged treatment (at least 6-12 hours).

Uncommon side effects, which may affect between 1 and 10 in 1,000 patients, are:

• Respiratory, thoracic, and mediastinal disorders: atelectasis (collapse of lung alveoli), dry cough, and pain associated with breathing.
• With oxygen at high pressure (hyperbaric oxygen therapy): disorders of the ear and labyrinth, such as a feeling of pressure in the middle ear and rupture of the eardrum.

Rare side effects, which may affect between 1 and 10 in 10,000 patients, are:

• Ocular disorders: in premature newborns, exposure to high concentrations of oxygen can cause eye damage that can affect vision (retrolental fibroplasia).

Very rare side effects, which may affect less than 1 in 10,000 patients, are:

• Respiratory, thoracic, and mediastinal disorders: severe difficulty breathing due to acute lung failure (Acute Respiratory Distress Syndrome).
• With oxygen at high pressure (hyperbaric oxygen therapy): disorders of the nervous system, such as anxiety, confusion, loss of consciousness, and epileptic convulsions.

Other side effects reported and of unknown frequency are:

• Apnea (interruption of breathing): in patients with chronic respiratory failure.
• Lesions in the nasal sinuses, pneumothorax (presence of air in the thoracic cavity), nausea, dizziness, pain, and muscle contraction with oxygen at high pressure (hyperbaric oxygen therapy).
• Claustrophobia crisis: in patients undergoing high oxygen pressures in hyperbaric chambers.
• Anemia.
• Affectation of different organs with high concentrations of oxygen in long-term treatments: heart (it can also decrease heart rate when 100% oxygen is administered for short periods), liver, kidneys, and lungs (pulmonary fibrosis).

If you think that any of the side effects you are suffering from is serious, or if you notice any side effect not mentioned in this leaflet, tell your doctor.

5. Storage of CONOXIA

Keep CONOXIA out of the reach and sight of children.

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

Storage of bottles:

Bottles must be stored in a well-ventilated or ventilated room, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked with a key.

Empty bottles and full bottles must be stored separately.

Bottles must be protected from the risk of shocks or falls, as well as from heat sources or ignition, temperatures equal to or above 50°C, and also from combustible materials and weather conditions.

Bottles with a capacity greater than 5 liters must be kept in a vertical position, with the valves closed.

Storage of bottles in the user service and at home:

The bottle must be installed in a location that allows protecting it from the risks of shocks and falls (such as a support with chains for fixation), heat sources or ignition, temperatures equal to or above 50°C, combustible materials, and weather conditions.

Excessive storage should be avoided.

Transportation of bottles:

Bottles must be transported with the help of suitable material (such as a cart with chains, barriers, or rings) to protect them from the risk of shocks or falls. Special attention should be paid to fixing the reducer to avoid accidental rupture risks.

During transportation in vehicles, bottles must be well secured, preferably in a vertical position. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Expiration date

Do not use CONOXIAafter the expiration date that appears on the packaging. The expiration date is the last day of the month indicated.

6. ADDITIONAL INFORMATION

Composition ofCONOXIA:

• The active ingredient is Oxygen.
• Without excipients.

Appearance of the product and packaging content ofCONOXIA:

CONOXIAis packaged in gas cylinders at 200 bar pressure at 15°C. The bottles may be of different sizes and different materials with an outlet valve through which the gas is extracted. Some of the valves are protected by a tulip.

The bottles may be of the following volumes: (Not all packaging sizes are marketed).

• 2-liter bottle.
• 2-liter LIV bottle.
• 2-liter LIV IQ bottle.
• 2.5-liter bottle.
• 3-liter bottle.
• 3-liter LIV bottle.
• 5-liter bottle.
• 5-liter LIV bottle.
• 5-liter LIV IQ bottle.
• 10-liter bottle.
• 10-liter LIV IQ bottle.
• 20-liter bottle.
• 30-liter bottle.
• 50-liter bottle.
• Blocks of 12 bottles of 50 liters (total 600 liters).

Marketing authorization holder and manufacturer:

Marketing authorization holder

Holder Laboratory:

LINDE GAS ESPAÑA, S.A.U.

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

Phone numbers: 93.476.74.00 and 902.426.462

Manufacturer

Linde Gas España, S.A.U., Polígono industrial Bañuelos C/ Haití, 1 Alcalá de Henares (Madrid)- 28806 - Spain

Linde Gas España, S.A.U,, P.I. Can Pí de Vilaroch, Avd. Antonio Gaudí, 151; Rubí, 08191 Barcelona, Spain.

Linde Gas España, S.A.U, Camino de Liria, s/n- Puçol (Valencia) - 46530 Spain-

Linde Gas España, S.A.U, P.I. Ciudad de transporte P-27, Jerez de la Frontera (Cádiz) - 11591- Spain.

Linde Portugal, Lda. Loteamento Vilar do Senhor, Unidade J; Vila Nova da Telha – 4470-777- Portugal.

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

INSTRUCTIONS FOR USE/MANIPULATION FOR HEALTH PROFESSIONALS AND PATIENTS (See Section 5)

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 of a fatty nature.
• Never clean with combustible products, especially if they are of a fatty nature, neither the devices that contain this gas nor the valves, nor the gaskets, nor the seals, nor the closing devices.
• Never apply any greasy material (vaseline, ointments, etc.) to the face of patients who inhale the gas.
• Never use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on the material or near it.

TheCONOXIAbottles are reserved exclusively for therapeutic use.

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

1. Verify the good condition of the material before its use.
2. Group bottles of capacity greater than 5 liters with a suitable means (chains, hooks, etc.) to keep them in a vertical position and avoid any unexpected fall.
3. Do not use the bottles if their pressure is less than 10 bar.
4. Never force a bottle into a support that is too narrow for it.
5. Handle the material with clean and grease-free hands.
6. Handle bottles of 50 liters or greater capacity with clean handling gloves and safety shoes.
7. Verify, at the time of delivery by the manufacturer, that the bottle is provided with an intact tamper-evident system.
8. Do not handle a bottle whose valve is not protected by a tulip, except in bottles of capacity less than 5 liters.
9. Do not lift the bottle by holding it by the valve.
10. Use specific connections or flexible connection elements for Oxygen.
11. Use a manoreducer with a flowmeter that admits a pressure of at least 1.5 times the maximum service pressure (200 bar) of the bottle (unless there is already a reducer incorporated into the valve).
12. In the case of blocks of bottles, use only manometers graduated to at least 315 bar.
13. Use flexible connection elements in wall outlets provided with specific nozzles for Oxygen.
14. Open the valve progressively.
15. Never force the valve to open, nor open it all the way.
16. Purge the outlet connection of the bottle before incorporating the manoreducer to eliminate any dust that may be present. Keep the connections between the bottle and the manoreducer clean.
17. Never subject the manoreducer to several successive pressurizations.
18. Never place yourself in front of the valve outlet, but always on the opposite side of the manoreducer, behind the bottle and backwards. Never expose patients to the gas flow.
19. Do not use intermediate connections to allow the connection of two devices that do not fit together.
20. Do not attempt to repair a faulty valve.
21. Never tighten the manoreducer-flowmeter with pliers, under the risk of causing damage to the gasket.
22. Verify previously the compatibility of the materials in contact with Oxygen, using in particular connection gaskets of the manoreducer special for Oxygen.
23. Close the bottle valve after its use, allow the pressure of the manoreducer to decrease by leaving the flowmeter open, close the flowmeter and then loosen (except in the case of integrated manoreducers) the regulation screw of the manoreducer.
24. In case of leakage, close the valve that has a leak and check that the emergency device is activated.
25. Never completely empty a bottle.
26. Keep the bottles and blocks with the valve closed to avoid corrosion processes in the presence of internal humidity.
27. Never transfer gas under pressure from one bottle to another.
28. Ventilate, if possible, the place of use, if it is reduced locations (vehicles, home).

This prospectus was approved in: May 2009.

This information is intended only for healthcare professionals:

Posology

The posology depends on the patient's clinical condition. The dose of oxygen should be adjusted according to the individual requirements of each patient and taking into account the risk of oxygen intoxication.

Oxygen therapy aims, in any case, to maintain an arterial partial oxygen pressure (PaO2) greater than 60 mm Hg (i.e., 7.96 kPa) or an oxygen saturation in arterial blood greater than or equal to 90%,

If oxygen is administered diluted in another gas, its minimum concentration in the inhaled air must be 21%, i.e., the inspired fraction (Fi O2) must be 21%, and may reach a concentration of 100%.

Warnings and precautions for use

-In certain severe cases of hypoxia, the therapeutic dose approaches the threshold of toxicity. 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.

-Important concentrations should be used for the shortest possible time and controlled by analyzing the gases in arterial blood, while measuring the concentration of inhaled oxygen; it is convenient to use, in any case, the smallest dose capable of maintaining the arterial partial oxygen pressure (Pa O2) at 50-60 mmHg (i.e., at 5.65-7.96 kPa) and, after 24 hours of exposure, try to maintain, as far as possible, an oxygen concentration less than 45%.

-In neonates and premature babies, it is necessary to use the lowest possible concentration that has the desired effect to minimize the risk of eye damage, retrolental fibroplasia, or other possible undesirable effects. For infants who need an oxygen concentration (Fi O2) greater than 30%, the Pa O2 concentration should be regularly controlled so that it does not exceed 100 mmHg (i.e., 13.3 kPa) due to the risk of alterations in the retina.

-Whenever oxygen is used, the increased risk of spontaneous ignition and fire should be taken into account. This risk increases when working with diathermy processes, and defibrillation and electroconversion therapies.