Prospect: information for the user

CONOXIA, medicinal gas compressed

Medicinal Oxygen 99.5% (v/v)

Read this prospect carefully before starting to usethis medication.

Keep this prospect, as you may need to read it again.
If you have any doubts, consult yourdoctororpharmacist.

This medication has been prescribed to you, and you must not give it to other people even if they have the same symptoms, as it may harm them.

Ifyou consider that any of the adverse effects you are experiencing is severe or if you notice any adverse effect not mentioned in this prospect, inform your doctor or pharmacist.

1. What isCONOXIAand for what it is used

2. BeforeusingCONOXIA

3. How to useCONOXIA

4. Possible adverse effects

5. Storage ofCONOXIA

6. Information additional

CONOXIAis an inhalation gas that belongs to a group of medications 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.

The oxygen treatment is indicated in the following cases:

-Correction of oxygen deficiency of different origins that require oxygen administration at normal or elevated pressure.

-Supplying ventilators in anesthesia - resuscitation.

-Administration through nebulizer of inhalation medications.

-Treatment of acute phases of Cluster Headaches (Cluster Headache or Cephalalgia in Bunches).

No use CONOXIA :

No there are any absolute contraindications for administering oxygen when its use is necessary.

Tenga especial cuidado con CONOXIA :

-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 of this.

-Because it can be toxic to the lungs or the nervous system depending on the concentration and the time during which it is applied (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, fabrics, wood, paper, plastics, etc. (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 oxygen concentrations (see Section 4).

Use of other medications and other forms of interaction

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

The toxicity of CONOXIA may be increased if used at the same time as other medications that also affect the lungs: corticosteroids, some cancer medications (bleomycin), sympathomimetics. It may also occur when using paraquat, X-rays, or in cases of hyperthyroidism or vitamin C and E deficiency or glutathione deficiency.

Pregnancy and breastfeeding

It has been widely used without any notable effect.

Driving and using machines

There is no data on the effect of medicinal oxygen on driving and using machines, therefore it is possible to drive but with extreme caution.

Follow exactly the oxygen administration instructions indicated by your doctor.

CONOXIAis used by inhalation

Your doctor will determine the correct dose of medicinal oxygen and administer it through an appropriate system for your needs that will ensure the supply of the correct amount of oxygen.

Dosage. The usual dose is:

- In patients who breathe spontaneously (spontaneous ventilation) and with acute respiratory failure, oxygen is administered at a flow rate of 0.5 to 15 liters/minute. This may vary according to the results of the analyses performed (blood gas analysis).

- In patients who breathe spontaneously (spontaneous ventilation) and with chronic respiratory failure, oxygen is administered at a flow rate of 0.5 to 2 liters/minute. This may vary according to the results of the analyses performed (blood gas analysis).

- In patients with acute phases of Cluster Headache (Cluster Headache type), oxygen administration should be performed as soon as possible after the onset of the acute phase, at a flow rate of between 7 and 15 liters/minute, and for 15 minutes or until the pain disappears. 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 achieve effectiveness. Oxygen administration should be stopped if no effect is found after 15 or 20 minutes.

- In patients who require assistance with breathing (assisted ventilation), oxygen should be administered at a dose that allows a minimum oxygen concentration of 21%, which can reach up to 100%.

Administration form

- 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 with ventilation problems, or who are anesthetized, oxygen is administered through special devices such as endotracheal tube, laryngeal mask, through a tracheotomy that allows assisted ventilation, or others.

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

- Oxygen administration 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 clinical condition of the patient.

Treatment duration

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

- 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 next 24 hours.

- Any oxygen concentration above 40% is potentially toxic after 2 days.

If you estimate that the action of CONOXIA is too strong or too weak, inform your doctor. Read the usage instructions carefully (see Section 6).

If You Use MoreCONOXIAthan You Should:

In case of excessive use of oxygen, reduce the concentration of inhaled oxygen 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, produce carbon dioxide anesthesia or unconsciousness.

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

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

Like all medications,CONOXIAmay cause adverse effects, although not everyone will experience them. When oxygen is administered through nasal glasses, it may cause dryness of the nasal and labial mucosa.

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

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

- Respiratory, thoracic, and mediastinal disorders: atelectasis (alveolar lung collapse), dry cough, and respiratory pain.

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

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

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

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

- Respiratory, thoracic, and mediastinal disorders: severe difficulty breathing due to acute pulmonary 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 and unknown frequency are:

- Apnea (breathing interruption): in patients with chronic respiratory insufficiency.

- Nasal sinus lesions, pneumothorax (presence of air in the thoracic cavity), nausea, dizziness, pain, and muscle contraction with high-pressure oxygen (hyperbaric oxygen therapy).

- Panic attacks: in patients undergoing high oxygen pressures in hyperbaric chambers

- Anemia.

- Affection of different organs with high oxygen concentrations in long-term treatments: heart (it can also decrease heart rate when oxygen is administered at 100% for short periods), liver, kidneys, and lungs (pulmonary fibrosis).

If you consider that any of the adverse effects you are experiencing are severe or if you notice any adverse effect not mentioned in this prospectus, inform your doctor.

Keep CONOXIA out of reach and sight of children.

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

Storage of bottles:

Bottles must be stored in a well-ventilated or air-conditioned area, protected from the elements, clean, free from flammable materials, reserved for the storage of medical gases, and capable of being locked.

Empty and full bottles must be stored separately.

Bottles must be protected from the risk of impacts or falls, as well as from heat sources or ignition, temperatures equal to or greater than 50º C, and combustible materials and weather conditions.

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

Storage of bottles in the user service and at home:

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

Excessive storage must be avoided.

Transportation of bottles:

Bottles must be transported with the help of suitable material (such as a cart equipped with chains, barriers, or rings) to protect them from the risk of impacts or falls. Special attention must be paid to securing the reducer to avoid accidental ruptures.

During transportation in vehicles, bottles must be securely fastened, preferably in an upright position. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Expiration Date

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

Composition ofCONOXIA:

- The active principle is Oxygen.

- Without excipients.

Aspect of the product and content of the containerCONOXIA:

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

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

- 12-bottle blocks of 50 liters (total 600 liters).

Holder of the marketing authorization and responsible for manufacturing:

Holder of the marketing authorization

Marketing Authorization Holder:

LINDE GAS ESPAÑA, S.A.U.

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

Phones: 93.476.74.00 and 902.426.462

Responsible for manufacturing

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.

The detailed and updated information of this medicine is available on the website of the Spanish Agency for Medicines and Medical Devices (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.

Particularly:

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

- Do not clean with combustible products, especially if they are of a greasy nature, nor the apparatus containing this gas nor the valves, nor the joints, nor the gaskets, nor the closure devices.

- Do not apply any greasy substance (vaseline, ointments, etc.) to the face of patients who inhale the gas.

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

The CONOXIA bottles are reserved exclusively for therapeutic use..

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

1. Verify the good condition of the material before its use.

2. Group the bottles with a capacity greater than 5 liters with a suitable medium (chains, hooks, etc.) to maintain it in a vertical position and avoid any unexpected fall.

3. Do not use the bottles if their pressure is less than 10 bar.

4. Do not force a bottle into a support that is too narrow for it.

5. Handle the material with clean and grease-free hands.

6. Handle the 50-liter or larger capacity bottles with clean manipulation gloves and safety shoes.

7. Verify at the time of delivery by the manufacturer that the bottle is provided with an intact inviolability guarantee system.

8. Do not manipulate a bottle whose valve is not protected by a tulip, except for bottles with a capacity less than 5 liters.

9. Do not lift the bottle by the valve.

10. Use specific connections or flexible connection elements for oxygen.

11. Use a pressure reducer with a flowmeter that can admit a pressure of at least 1.5 times the maximum service pressure (200 bar) of the bottle (except if there is already a built-in reducer on the valve).

12. In the case of bottle blocks, use only graduated pressure gauges of at least 315 bar.

13. Use flexible connection elements in wall-mounted outlets provided with specific nozzles for oxygen.

14. Open the valve gradually.

15. Do not force the valve to open it, nor open it completely.

16. Purge the outlet connection of the bottle before incorporating the pressure reducer to eliminate any dust that may have accumulated. Keep the connections between the bottle and the pressure reducer clean.

17. Do not subject the pressure reducer to multiple successive pressurizations.

18. Do not position yourself in front of the valve outlet, but always on the opposite side of the pressure reducer, behind the bottle and towards the back. Do not 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 defective valve.

21. Do not clamp the pressure reducer-flowmeter with pliers, under risk of causing defects in the joint.

22. Verify in advance the compatibility of the materials in contact with oxygen, using in particular special joints for oxygen connection on the pressure reducer.

23. Close the bottle valve after use, allow the pressure in the pressure reducer to decrease by leaving the flowmeter open, close the flowmeter and then loosen the pressure reducer adjustment screw (except in the case of integrated pressure reducers).

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

25. Do not empty a bottle completely.

26. Store the bottles and blocks with the valve closed to avoid corrosion processes in the presence of internal humidity.

27. Do not transfer gas under pressure from one bottle to another.

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

This prospectus was approved in: May 2009.

This information is intended only for healthcare professionals:

Dosage

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

Oxygen therapy aims to maintain a partial pressure of oxygen in the arterial blood (PaO2) greater than 60 mmHg (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 inspired air should be 21%, i.e., the inspired fraction (Fi O2) should be 21%, which can reach a 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 an oxygen concentration of 100%, or after 24 hours of exposure to an oxygen concentration greater than 70%, pulmonary or neurological toxicity may appear.

- Important concentrations should be used for the shortest possible time and should be controlled by analyzing the gases in the arterial blood, at the same time as measuring the inhaled oxygen concentration; it is advisable to use, in any case, the smallest dose capable of maintaining the partial pressure of oxygen in the arterial blood (PaO2) at 50-60 mmHg (i.e., at 5.65-7.96 kPa) and, after 24 hours of exposure, to try to maintain an oxygen concentration of 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 PaO2 concentration should be regularly controlled to avoid exceeding 100 mmHg (i.e., 13.3 kPa) due to the risk of retinal alterations.

- 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 cardioversion and defibrillation therapies.