MEDICAL OXYGEN OXIPHARMA GAS, 99.5% V/V COMPRESSED MEDICAL GAS

Introduction

Leaflet: Information for the Patient

Medicinal Oxygen Gas Oxipharma, 99.5% v/v compressed medicinal gas

Read the entire leaflet carefully before starting to use the medication.

• Keep this leaflet, as you may need to read it again.
• If you have any doubts, consult your doctor or pharmacist.
• This medication has been prescribed to you and should not be given to others, even if they have the same symptoms, as it may harm them.
• If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, inform your doctor or pharmacist.

Contents of the Leaflet:

1. What Oxígeno Medicinal Gas Oxipharma is and what it is used for.
2. What you need to know before starting to use Oxígeno Medicinal Gas Oxipharma
3. How to use Oxígeno Medicinal Gas Oxipharma
4. Possible adverse effects
5. Storage of Oxígeno Medicinal Gas Oxipharma
6. Package contents and additional information

1. What Oxígeno Medicinal Gas Oxipharma is and what it is used for

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

• Correction of oxygen deficiency of different origins that require the administration of oxygen at normal or high pressure.
• Feeding of respirators in anesthesia - resuscitation.
• Administration of medications for inhalation via a nebulizer.

2. What you need to know before starting to use Oxígeno Medicinal Gas Oxipharma

Do not 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 use of the gas. However, the most significant risks of inflammation in the presence of oxygen are those associated with combustible compounds, especially those of a fatty nature (lubricants, oils) and organic materials (plastic materials, wood, paper, fabrics) that can ignite when in contact with oxygen, either spontaneously or under the effect of a spark, a flame, or point of ignition, or under the effects of adiabatic compression.

Be careful with Oxígeno Medicinal Gas Oxipharma

• In certain severe cases of oxygen deficiency. After 6 hours of exposure to an oxygen concentration of 100%, or after 24 hours of exposure to an oxygen concentration above 70%, pulmonary or neurological toxicity may appear.
• High concentrations should be used for the shortest possible time and controlled through the analysis of gases in arterial blood, while measuring the concentration of inhaled oxygen; it is convenient to use, in any case, the lowest dose capable of maintaining the arterial partial oxygen pressure (PaO2) at 50-60 mmHg (i.e., 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 arterial partial oxygen pressure (PaO2) should be regularly controlled so that it does not exceed 100 mmHg (i.e., 13.3 kPa) due to the risk of retinal alterations.
• Hyperbaric oxygen therapy: in order to avoid risks of injuries caused by high pressure, in body cavities that contain air and are in communication with the outside, compression and decompression should be slow.

Using Oxígeno Medicinal Gas Oxipharma with other medications

Tell your doctor or pharmacist if you are recently using other medications, including those purchased without a prescription. The toxicity of oxygen may be increased by: corticosteroids, some cancer medications, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione.

Pregnancy and breastfeeding

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

Driving and using machines

There is no data on the effect of Oxígeno Medicinal Gas Oxipharma on driving and using machines.

3. How to use Oxígeno Medicinal Gas Oxipharma

Follow exactly the administration instructions of Oxígeno Medicinal Gas Oxipharma indicated by your doctor. Consult your doctor or pharmacist if you have doubts.

The doctor will determine the correct dose of Oxígeno Medicinal Gas Oxipharma and will administer it through a system suitable for your needs that guarantees the supply of the correct amount of oxygen.

If you think that the action of Oxígeno Medicinal Gas Oxipharma is too strong or weak, tell your doctor.

If you use more Oxígeno Medicinal Gas Oxipharma than you should.

The concentration of inhaled oxygen should be decreased and symptomatic treatment is recommended.

If you stop treatment with Oxígeno Medicinal Gas Oxipharma

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

4. Possible adverse effects

Like all medications, Oxígeno Medicinal Gas Oxipharma can cause adverse effects, although not everyone experiences them.

In chronic respiratory failure, in particular, there is a possibility of apnea.

Inhaling high concentrations of oxygen can cause small lung collapses.

Administering oxygen at high pressures can cause damage to the inner ear (which can lead to a risk of eardrum rupture), sinuses, lungs (which can lead to 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.

Lung damage can occur after administration of oxygen concentrations above 80%.

In newborns, especially if premature, exposed to high concentrations of oxygen (FiO2 > 40%; PaO2 above 80 mmHg, i.e., 10.64 kPa) or for a prolonged period (more than 10 days at a concentration FiO2 > 30%), there is a risk of retinopathy, which appears between 3 and 6 weeks after treatment, and may experience regression or cause retinal detachment, or even permanent blindness.

Patients undergoing high oxygen pressures in chambers may experience claustrophobia crises.

If you consider that any of the adverse effects you are experiencing is serious or if you notice any adverse effect not mentioned in this leaflet, 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 that is not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Storage of Oxígeno Medicinal Gas Oxipharma

Keep out of the reach and sight of children.

Do not use Oxígeno Medicinal Gas Oxipharma after the expiration date shown on the packaging.

All regulations regarding the handling of pressure vessels must be followed.

Regarding storage and transportation, the following should be taken into account:

Storage of gas cylinders:

Gas cylinders should be stored in a well-ventilated or ventilated area, protected from the weather, clean, without flammable materials, reserved for the storage of medical gases, and can be locked. Empty gas cylinders and full gas cylinders should be stored separately. Gas cylinders should 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 combustible materials and weather conditions. Gas cylinders with a capacity greater than 5 L should be kept in a vertical position, with the valves closed.

Storage of gas cylinders in the user service and at home:

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

Excessive storage should be avoided.

Transportation of gas cylinders:

Gas cylinders should 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 breakage risks. During transportation in vehicles, gas cylinders should be securely grouped. Permanent ventilation of the vehicle is mandatory, and smoking is strictly prohibited.

6. Package contents and additional information

Composition of Oxígeno Medicinal Gas Oxipharma

• The active ingredient is Oxygen in a concentration above 99.5% v/v

Appearance of the product and package contents

Gas cylinders at 200 bar pressure at 15°C. Gas cylinders can be made of steel, compact steel, aluminum, or compact aluminum with 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 pack sizes may be marketed.

Marketing authorization holder and manufacturer

OXIPHARMA, S.L.

Pol. Ind. Lentiscares, Parc. 18

26370 Navarrete (La Rioja)

Date of the last revision of this leaflet: 10/2005

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.gob.es

_____________________________________________________________________________

This information is intended only for healthcare professionals:

Instructions for use/manipulation

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 the devices that contain this gas or the valves, gaskets, seals, closing devices, and valves with combustible products, especially if they are of a fatty nature;
• Never apply any greasy material (vaseline, ointments...) to the face of patients;
• Never use aerosols (lacquer, deodorant...) or solvents (alcohol, perfume...) on the material or near it.

Medicinal oxygen gas cylinders are exclusively reserved for therapeutic use.

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

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