Medication Information for the Patient

Oxipharma Medical Gas Oxygen, 99.5% v/v compressed medical gas

Read this entire medication guide carefully before starting to use the medication.

- Keep this guide, as you may need to refer to it again.

- If you have any questions, consult your doctor or pharmacist.

- This medication has been prescribed for you and should not be given to others, even if they have the same symptoms, as it may harm them.

- If you consider any of the adverse effects you are experiencing to be severe or if you notice any adverse effect not mentioned in this guide, inform your doctor or pharmacist.

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

• Correction of oxygen deficiency from various sources requiring oxygen administration at normal or elevated pressure.
• Supplying oxygen to ventilators during anesthesia – resuscitation.
• Administration of inhalation medications via nebulizer.

No use Oxígeno Medicinal Gas Oxipharma

With flammable materials.

Oxygen allows and accelerates combustion. The degree of incompatibility of materials with oxygen depends on the conditions of pressure of use of the gas. However, the most important risks of inflammation in the presence of oxygen, highlighting those associated with combustible compounds, especially those of fatty nature (lubricants, oils) and to organic materials (plastic materials, wood, paper, textiles) that can ignite upon contact with oxygen, either spontaneously or under the effect of a spark, a flame or ignition point, or under the effects of adiabatic compression.

Be especially careful with Oxígeno Medicinal Gas Oxipharma

• 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 an oxygen concentration above 70%, pulmonary or neurological toxicity may appear.
• High concentrations must be used for the shortest possible time and controlled by analyzing the gases in arterial blood, at the same time as measuring the concentration of inhaled oxygen; 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., at 5.65-7.96 kPa) and, after 24 hours of exposure, try to maintain, as far as possible, an oxygen concentration below 45%.

Precautions for use

• For infants who need a concentration above 30%, the partial pressure of arterial oxygen (PaO2) must be regularly controlled to prevent it from exceeding 100 mmHg (i.e., 13.3 kPa) due to the risk of appearance of retinal alterations.
• Hyperbaric oxygen therapy: in order to avoid risks of 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.

Use of Oxígeno Medicinal Gas Oxipharma with other medications

Inform your doctor or pharmacist if you are using recently other medications, even those acquired without a prescription. Oxygen toxicity can 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

Consult your doctor or pharmacist before using any medication. It has been widely used without any notable effect.

Driving and use of machines

There are no data on the action of Oxígeno Medicinal Gas Oxipharma on driving and machine use.

Follow exactly the administration instructions for Medical Oxygen Gas Oxipharma as indicated by your doctor. Consult your doctor or pharmacist if you have any doubts.

Your doctor will determine the correct dose of Medical Oxygen Gas Oxipharma and administer it through an appropriate system that will ensure the supply of the correct amount of oxygen.

If you estimate that the action of Medical Oxygen Gas Oxipharma is too strong or weak, inform your doctor.

If you use more Medical Oxygen Gas Oxipharma than you should.

Reduce the concentration of inhaled oxygen and symptomatic treatment is recommended.

If you interrupt treatment with Medical Oxygen Gas Oxipharma

If you have any other doubts about the use of this product, ask your doctor or pharmacist.

Like all medications, Medical Oxygen Gas Oxipharma may produce adverse effects, although not all people will experience them.

In particular, chronic respiratory insufficiency may lead to the possibility of apnea.

Inhalation of high oxygen concentrations may cause small lung collapses.

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

Seizures have been reported after administration of oxygen with a concentration of 100% 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 greater than 80 mmHg, i.e., 10.64 kPa) or for an extended period (more than 10 days at a FiO2>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 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 or pharmacist.

Reporting Adverse Effects

If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicinal Products for Human Use:https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

Keep out of reach and sight of children.

Do not use Oxipharma Medical Oxygen Gas after the expiration date that appears on the packaging.

All guidelines for handling pressure containers must be followed..

The following must be taken into account in relation to storage and transportation:

Storage of gas cylinders:

Gas cylinders 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 gas cylinders must be stored separately. Gas cylinders must be protected from the risk of impacts or falls, as well as from heat sources or ignition, temperatures equal to or greater than 50°C, and combustible materials and weather conditions. Gas cylinders with a capacity greater than 5 liters must be kept in an upright position, with the valves closed.

Storage of gas cylinders at the user's service and at home:

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

Excessive storage must be avoided.

Transportation of gas cylinders:

Gas cylinders 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, gas cylinders must be solidly grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

Composition of Medical Oxygen Gas Oxipharma

- The active ingredient is Oxygen in a concentration greater than 99.5% v/v

Aspect of the product and contents of the packaging

Oxygen gas cylinders at 200 bars of pressure at 15°C. The gas cylinders can be made of steel, compact steel, aluminum, or compact aluminum of the following volumes: 0.8 L, 1 L, 1.2 L, 1.34 L, 1.5 L, 1.8 L, 2 L, 2.7 L, 3 L, 3.5 L, 4 L, 4.75 L, 5 L, 6.7 L, 7 L, 7.5 L, 8 L, 10 L, 12 L, 13.4 L, 15 L, 18 L, 20 L, 25 L, 26.8 L, 30 L, 35 L, 40 L, 45 L, and 50 L (expressed in liters)

Not all packaging sizes may be commercially available.

Holder of the marketing authorization and responsible for manufacturing

OXIPHARMA, S.L.

Pol. Ind. Lentiscares, Parc. 18

26370 Navarrete (La Rioja)

Date of the last review of this prospectus: 10/2005

Detailed and updated information on this medication 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.

In particular:

Oxygen medical gas cylinders are reserved exclusively for therapeutic use.

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

1. Verify the good condition of the material before its use.
2. Group the oxygen gas cylinders with a capacity greater than 5 L with a suitable medium (chains, hooks...) to keep them in a vertical position and prevent any accidental fall; do not use the gas cylinders if their pressure is less than 10 bars.
3. Never force a gas cylinder into a support that is too narrow for it.
4. Manipulate the material with clean and grease-free hands.
5. Manipulate the 50 L or larger gas cylinders with clean handling gloves and safety shoes.
6. Verify in advance that the gas cylinder is provided with an intact inviolability guarantee system at the time of delivery by the manufacturer.
7. Never manipulate a gas cylinder whose faucet is not protected by a tulip, except for gas cylinders with a capacity less than 5 L.
8. Never lift the gas cylinder by the faucet.
9. Use specific oxygen connections or flexible connection elements.
10. Use a pressure reducer with a flowmeter that can admit a pressure of at least 1.5 times the maximum service pressure (200 bars) of the gas cylinder (except if there is already a built-in reducer on the faucet).
11. In the case of gas cylinder racks, use only pressure gauges graduated at least to 315 bars.
12. Use flexible connection elements on wall-mounted outlets provided with specific oxygen nozzles.
13. Open the faucet or valve gradually.
14. Never force the faucet to open it, nor open it completely.
15. Purge the outlet connection of the gas cylinder before incorporating the pressure reducer to eliminate any dust that may have accumulated. Keep the connections between the gas cylinder and the pressure reducer clean.
16. Never subject the pressure reducer to multiple successive pressurizations.
17. Never position yourself in front of the faucet outlet, but always on the opposite side of the pressure reducer, behind the gas cylinder, and to the rear. Never expose patients to the gas flow.
18. Never use intermediate connections to allow the connection of two devices that do not fit together.
19. Never attempt to repair a faulty faucet.
20. Never clamp the pressure reducer-flowmeter with pliers, under risk of causing defects in the joint.
21. Verify in advance the compatibility of the materials in contact with oxygen, using in particular special connection joints for the pressure reducer.
22. Close the faucet of the gas cylinder after its use, allow the pressure of the pressure reducer to decrease while keeping the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated pressure reducers) the adjustment screw of the pressure reducer.
23. In case of a leak, close the faucet or valve of the feeding circuit that has a defect in tightness. Never use a gas cylinder that presents a leak, and check that the emergency device is activated.
24. Never empty a gas cylinder completely.
25. Store empty gas cylinders with the faucet closed and empty racks with the valve closed (to prevent corrosion processes in the presence of humidity).
26. Never transfer gas under pressure from one gas cylinder to another.
27. Ventilate if possible the area of use, if it is a reduced location (vehicle, home).