Conoxia medicinal gas tablet

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

CONOXIA, compressed medicinal gas

Medicinal Oxygen 99.5% (v/v)

Read the entire leaflet carefully before you start using this medicine.

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

This medicine has been prescribed for you; do not give it to others, even if they have the same symptoms, as it may harm them.

If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effect not listed in this leaflet, inform your doctor or pharmacist.

Contents of the leaflet

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

1. What CONOXIA is and what it is used for

CONOXIA is an inhalation gas belonging to a group of medicines called medicinal gases. It is supplied in pressurized cylinders containing pure oxygen only.

Oxygen is an essential element for the body and is administered to increase its levels in the blood, thereby achieving improved oxygen delivery to all body tissues.

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 ventilators during anesthesia and resuscitation.
• Administration via nebulizer of inhaled medications.
• Treatment of acute phases of Cluster Headaches (Cluster Headache or Cefalea en Racimos).

2. BEFORE USING CONOXIA

Do not useCONOXIA:

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

Take special care withCONOXIA:

• If you suffer from a chronic lung disease such as bronchitis, emphysema, or asthma, and in severe situations of oxygen deficiency. You must inform your doctor about this.

• Because it may be toxic to the lungs or the nervous system depending on the concentration and duration of administration (see Section 3 and Section 6).

Precautions for use

• Do not apply any greasy substances (e.g., vaseline, ointments, etc.) to the patient's face due to the risk of combustion (see Section 6).

• Oxygen must not be used in the presence of flammable materials: oils, lubricants, fabrics, wood, paper, plastic materials, etc. (see Section 6).

• When oxygen is administered under high pressure (hyperbaric oxygen therapy), injuries may occur due to pressure changes in body cavities containing air that communicate with the outside. To avoid risks, compression and decompression must be performed slowly (see Section 4).

Use in children

In newborns, especially premature infants, certain oxygen concentrations may cause eye damage (retrolental fibroplasia) (see Section 4).

Use of other medicines and other forms of interaction

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

The toxicity of CONOXIA may be increased if used simultaneously with other medicines that may also affect the lungs: corticosteroids, certain anticancer drugs (bleomycin), sympathomimetics. This may also occur when using paraquat, X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione deficiency.

Pregnancy and breastfeeding

Oxygen has been widely used without any notable adverse effects.

Driving and use of machines

There are no data regarding the effects of medicinal oxygen on driving and operating machinery; therefore, driving is permitted but with extreme caution.

3. How to use CONOXIA

Follow exactly the oxygen administration instructions provided by your doctor.

CONOXIA is used by inhalation.

Your doctor will determine the correct dose of medicinal oxygen and administer it to you via a system appropriate to your needs, ensuring delivery 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 test results (blood gas analysis).
• 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 test results (blood gas analysis).
• In patients experiencing acute episodes of cluster headache (cluster-type headache), oxygen administration should begin as soon as possible after the onset of the acute episode, at a flow rate of 7 to 15 liters/minute, for 15 minutes or until pain resolves. Typically, a flow rate of 7 to 10 liters/minute is sufficient; however, in some patients, increasing the flow up to 15 liters/minute may be necessary to achieve effectiveness. Oxygen administration should be discontinued if no effect is observed after 15 to 20 minutes.
• In patients requiring respiratory support (assisted ventilation), oxygen should be administered at a dose allowing attainment of a minimum oxygen concentration of 21%, up to 100%.

Method of administration

• In patients without ventilation problems: oxygen may be administered via spontaneous ventilation using nasal cannulas, a nasopharyngeal catheter, or a face mask, which should be adapted to the oxygen flow rate.

• In patients with ventilation problems or who are anesthetized: oxygen is administered using special devices such as an endotracheal tube, laryngeal mask, via tracheostomy allowing connection to assisted ventilation, or other devices.

• For the treatment of cluster headache: oxygen must be administered via a face mask in a non-rebreathing system.

• Administration of oxygen at high pressure (hyperbaric oxygen therapy) is performed in a hyperbaric chamber at a pressure of 2 to 3 atmospheres, with session durations ranging from 90 minutes to 2 hours. These sessions may be repeated 2 to 4 times daily, depending on clinical indications and the patient's condition.

Duration of treatment

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

• Oxygen concentrations up to 100% should not be administered for longer than 6 hours.
• Oxygen concentrations between 60–70% should not be administered for longer than 24 hours.
• Oxygen concentrations between 40–50% should not be administered continuously for the following 24 hours.
• Any oxygen concentration above 40% may become potentially toxic after 2 days.

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

If you use more CONOXIA than you should:

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

Prolonged overuse of oxygen may cause pain, dry cough, and breathing difficulty.

In some situations, excessive oxygen may affect respiration and, exceptionally, lead to anesthesia or unconsciousness due to carbon dioxide retention.

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

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

4. Possible adverse effects

Like all medicines, CONOXIA can cause adverse effects, although not everyone experiences them. When oxygen is administered via nasal glasses, it may cause dryness of the nasal and labial mucous membranes.

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

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

• Respiratory, thoracic and mediastinal disorders: atelectasis (collapse of pulmonary alveoli), dry cough, and pain associated with breathing.
• With high-pressure oxygen (hyperbaric oxygen therapy): Ear and labyrinth disorders such as sensation of pressure in the middle ear and rupture of the tympanic membrane.

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

• Eye 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 in 10,000 patients, are:

• Respiratory, thoracic and mediastinal disorders: severe difficulty in breathing due to acute lung 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 with unknown frequency are:

• Apnea (cessation of breathing): in patients with chronic respiratory failure.
• Sinus lesions, pneumothorax (presence of air in the thoracic cavity), nausea, dizziness, pain, and muscle twitching with high-pressure oxygen (hyperbaric oxygen therapy).
• Claustrophobia attacks: in patients undergoing high-pressure oxygen in hyperbaric chambers.
• Anaemia.
• Organ involvement with high oxygen concentrations during long-term treatment: heart (may also reduce heart rate when 100% oxygen is administered for short periods), liver, kidneys, and lungs (pulmonary fibrosis).

If you consider any of the adverse effects you experience to be severe or if you notice any adverse effects not listed in this leaflet, inform your doctor.

5. Storage of CONOXIA

Keep CONOXIA out of the reach and sight of children.

All regulations regarding the handling of pressurized containers must be followed. The following considerations apply to storage and transport:

Storage of cylinders:

Cylinders must be stored in a well-ventilated or ventilated area, protected from weather conditions, clean, free from flammable materials, reserved exclusively for the storage of medical gases, and capable of being locked.

Empty and full cylinders must be stored separately.

Cylinders must be protected from impact or falling, as well as from sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

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

Storage of cylinders at user facilities and in home settings:

The cylinder must be installed in a location that protects it from impact or falling risks (such as a stand with securing chains), sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

Excessive storage must be avoided.

Transport of cylinders:

Cylinders must be transported using appropriate equipment (such as a trolley equipped with chains, barriers, or rings) to protect them from impact or falling. Special attention must be paid to securing the pressure regulator to prevent accidental breakage.

During transport in vehicles, cylinders must be securely fastened, preferably in an upright position. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

Expiry date

Do not use CONOXIA after the expiry date stated on the packaging. The expiry date refers to the last day of the month indicated.

6. ADDITIONAL INFORMATION

Composition of CONOXIA:

• The active substance is Oxygen.
• No excipients.

Appearance of the product and contents of the container CONOXIA:

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

The cylinders may have the following capacities: (Not all container sizes are marketed).

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

Marketing Authorization Holder and Manufacturer:

Marketing Authorization Holder

Laboratory Holder:

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

INSTRUCTIONS FOR USE/HANDLING FOR HEALTHCARE PROFESSIONALS AND PATIENTS (See Section 5)

Do not smoke.
Do not bring near a flame.
Do not grease.

In particular:

• Never introduce this gas into a device suspected of containing combustible materials, especially if of a greasy nature.
• Never clean with combustible products, especially if of a greasy nature, either the devices containing this gas, or the valves, seals, gaskets, or closure devices.
• Do not apply any greasy substances (vaseline, ointments, etc.) to the face of patients inhaling the gas.
• Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

CONOXIA cylinders are reserved exclusively for therapeutic use.

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

1. Check the equipment is in good condition before use.
2. Securely fasten cylinders with a capacity greater than 5 liters using appropriate means (chains, hooks, etc.) to keep them in an upright position and prevent unexpected falls.
3. Do not use cylinders if the pressure is below 10 bar.
4. Never force a cylinder into a support that is too narrow.
5. Handle equipment with clean hands, free from grease.
6. Handle 50-liter cylinders or those of greater capacity using clean handling gloves and safety shoes.
7. At the time of delivery by the manufacturer, verify that the cylinder is equipped with an intact tamper-proof seal.
8. Do not handle a cylinder whose valve is not protected by a cap, except for cylinders with a capacity below 5 liters.
9. Never lift the cylinder by holding the valve.
10. Use connections or flexible connecting elements specifically designed for Oxygen.
11. Use a pressure regulator with a flowmeter capable of withstanding a pressure of at least 1.5 times the maximum service pressure (200 bar) of the cylinder (unless a regulator is already integrated into the valve).
12. In the case of cylinder blocks, use only pressure gauges calibrated to at least 315 bar.
13. Use flexible connecting elements on wall outlets equipped with nozzles specifically designed for Oxygen.
14. Open the valve gradually.
15. Never force the valve to open it, nor open it fully.
16. Purge the cylinder outlet connection before attaching the pressure regulator to remove any dust that may be present. Keep the connections between the cylinder and the pressure regulator clean.
17. Never subject the pressure regulator to repeated pressurizations.
18. Never stand directly in front of the valve outlet; always stand on the side opposite the pressure regulator, behind the cylinder and to the rear. Never expose patients directly to the gas flow.
19. Do not use intermediate connectors to connect two devices that do not fit together.
20. Do not attempt to repair a defective valve.
21. Never tighten the pressure regulator-flowmeter with pliers, as this may damage the seal.
22. Verify in advance the compatibility of materials in contact with Oxygen, particularly by using pressure regulator connection seals specifically designed for Oxygen.
23. After use, close the cylinder valve, allow the pressure in the pressure regulator to decrease by leaving the flowmeter open, then close the flowmeter and subsequently loosen (except in the case of integrated pressure regulators) the pressure regulator adjustment screw.
24. In case of leakage, close the valve exhibiting the leak and verify that the emergency device activates.
25. Never completely empty a cylinder.
26. Store cylinders and cylinder blocks with the valve closed to prevent corrosion due to internal moisture.
27. Never transfer pressurized gas from one cylinder to another.
28. Ventilate, if possible, the area of use, especially in confined spaces (vehicles, homes).

This leaflet was approved in: May 2009.

This information is intended for healthcare professionals only:

Dosage

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

In any case, the goal of oxygen therapy is to maintain an arterial partial pressure of oxygen (PaO₂) above 60 mmHg (i.e., 7.96 kPa) or an arterial blood oxygen saturation of at least 90%.

If oxygen is administered diluted in another gas, its minimum concentration in the inspired air must be 21%, i.e., the inspired fraction (FiO₂) must be 21%, up to a maximum concentration of 100%.

Warnings and precautions for use

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

• High oxygen concentrations should be used for the shortest possible time and monitored by arterial blood gas analysis, while simultaneously measuring the concentration of inhaled oxygen. In all cases, the lowest effective dose should be used to maintain the arterial partial pressure of oxygen (PaO₂) at 50–60 mmHg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, it is advisable, whenever possible, to maintain an oxygen concentration below 45%.

• In neonates and premature infants, the lowest possible concentration that achieves the desired effect should be used to minimize the risk of ocular damage, retrolental fibroplasia, or other potential adverse effects. For infants requiring an oxygen concentration (FiO₂) above 30%, PaO₂ should be monitored regularly to ensure it does not exceed 100 mmHg (i.e., 13.3 kPa), due to the risk of retinal damage.

• Whenever oxygen is used, the increased risk of spontaneous ignition and fire must always be considered. This risk is heightened during procedures involving diathermy, defibrillation, and electroconversion.