Keol-S compressed medicinal gas in gas cartridge
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the patient
KEOL-S
Medicinal compressed gas in gas cylinder
Medicinal oxygen 21.0 – 22.5% v/v
<Read the entire leaflet carefully before starting to use this medicine, because it contains important information for you.
- Keep this leaflet, as you may need to read it again.
- If you have any questions, consult your doctor.
- This medicine has been prescribed for you; do not give it to other people, even if they have the same symptoms, as it may harm them.
- If you consider any of the side effects you experience to be severe, or if you notice any side effects not listed in this leaflet, inform your doctor.
Leaflet contents
- What KEOL-S is and what it is used for
- Before using KEOL-S
- How to use KEOL-S
- Possible side effects
- How to store KEOL-S
- Further information
1. What KEOL-S is and what it is used for
KEOL–S is Medicinal Conditioned Synthetic Air pressurized at 150 bar and 200 bar in cylinders (gas bottles) and cylinder bundles. The cylinders may be made of steel, aluminum, or alloys.
KEOL–S is used in assisted respiration:
- Mechanical ventilation:
In anesthesia, resuscitation (reanimation), and ventilation: KEOL–S is used as the driving gas supply for respirators in assisted breathing.
- Nebulization:
In aerosol therapy (treatment with aerosols), KEOL–S is used as the carrier (transport) gas in treatment.
2. BEFORE USING KEOL-S
Do not use KEOL-S
? If the pressure is below 10 bar.
? When there is a flame nearby.
? When someone is smoking nearby.
Take special care with KEOL-S
? Cylinders must be installed in a location allowing them to remain in an upright position and protected from risks of impacts and falls (such as a holder with securing chains).
? Do not use intermediate connectors to connect two devices that do not fit together.
? Never stand in front of the valve outlet; always stand on the side opposite the pressure regulator, behind the cylinder and facing backwards.
? At the time of delivery from the manufacturer, verify that the cylinder is provided with an intact tamper-evident seal (security seal).
? Do not grease.
Use of other medicines
Inform your doctor if you are taking, or have recently taken, any other medicines, including those obtained without a prescription.
Pregnancy and breastfeeding
Consult your doctor before using any medicine.
Driving and operating machinery
KEOL–S does not affect your ability to drive or operate machinery.
3. How to use KEOL-S
Follow exactly the administration instructions for KEOL-S provided by your doctor. Consult your doctor if you have any doubts.
Your doctor will determine the correct dose of KEOL-S and administer it using a system appropriate to your needs, which will ensure the delivery of the correct amount of medicinal air.
If you feel that the effect of KEOL-S is too strong or too weak, inform your doctor.
If you interrupt treatment with KEOL-S: Your doctor will indicate the duration of your treatment with KEOL-S. Do not stop the treatment prematurely, as it may not be effective.
If you have any further questions about the use of this product, ask your doctor.
Instructions for use:
- Use specific connecting components for Medicinal Air.
- Never clamp the pressure-reducing valve – flowmeter with pliers, as this may damage the seal.
- Never completely empty a cylinder or block of cylinders; always maintain a minimum pressure of 10 bar.
- Store empty cylinders in an upright position with the valve closed.
4. Possible adverse effects
Like all medicines, KEOL-S may produce adverse effects, although not everyone will experience them.
No adverse effects are expected as long as the administration instructions provided are followed.
If you consider any of the adverse effects you experience to be severe, or if you notice any adverse effects not mentioned in this leaflet, inform your doctor or pharmacist.
5. Storage of KEOL-S
Keep out of the reach and sight of children.
Do not use KEOL-S after the expiry date stated on the container after EXP. The expiry date refers to the last day of the month indicated.
All regulations regarding the handling of pressurized containers must be observed.
With regard to storage and transport, the following considerations apply:
Storage of cylinders:
- Cylinders must be stored in a well-ventilated or ventilated area, protected from weather conditions, clean, free of 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 against 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.
Storage of cylinders at the user site:
- The cylinder must be installed in a location that protects it from impact or falling risks (such as a support with securing chains), sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.
- Excessive storage of containers should 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 reducer to prevent accidental rupture.
- During transport in vehicles, cylinders must be securely grouped together. Continuous ventilation of the vehicle is mandatory, and smoking is strictly prohibited.
6. INFORMATION FOR THE USER
Composition of KEOL-S
- The active substance in KEOL-S is Medicinal Oxygen. The concentration of Medicinal Oxygen is 21.0 – 22.5% v/v.
- The other component (excipient) is: Medicinal Nitrogen.
Presentation of the product and contents of the pack
KEOL-S is supplied in cylinders and cylinder bundles. Cylinders may be made of steel, aluminum, or alloys, with the following volumes:
A V18 B40 cylinder bundle pressurized to 150 bar contains 134.46 kg + 5% gas
A V16 B50 cylinder bundle pressurized to 150 bar contains 149.44 kg + 5% gas
A B2 cylinder pressurized to 200 bar contains 0.48 kg + 5% gas
A B2 Pin-Index cylinder pressurized to 200 bar contains 0.48 kg + 5% gas
A B3 cylinder pressurized to 200 bar contains 0.72 kg + 5% gas
A B5 cylinder pressurized to 200 bar contains 1.20 kg + 5% gas
A B7 cylinder pressurized to 200 bar contains 1.68 kg + 5% gas
A B10 cylinder pressurized to 200 bar contains 2.40 kg + 5% gas
A B15 cylinder pressurized to 200 bar contains 3.60 kg + 5% gas
A B20 cylinder pressurized to 200 bar contains 4.80 kg + 5% gas
A B40 cylinder pressurized to 200 bar contains 9.59 kg + 5% gas
A B50 cylinder pressurized to 200 bar contains 11.99 kg + 5% gas
A V12 B50 cylinder bundle pressurized to 200 bar contains 143.88 kg + 5% gas
A V16 B50 cylinder bundle pressurized to 200 bar contains 195.00 kg ± 5% gas
A V18 B40 cylinder bundle pressurized to 200 bar contains 172.62 kg ± 5% gas
Instructions for use and handling intended for healthcare professionals
In particular:
. Never introduce this gas into equipment suspected of containing flammable substances, especially those of a greasy nature.
. Never clean with flammable products, particularly those of a greasy nature, either the equipment containing this gas or the valves, seals, gaskets, or closure devices.
. Never apply greasy substances (e.g., vaseline, ointments, etc.) to the patient's face.
. Do not use aerosols (hairspray, deodorants, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.
KEOL-S cylinders are intended exclusively for therapeutic use.
To prevent any accidents, the following rules must be strictly observed:
- Check the equipment is in good condition before use.
- Never force a cylinder into a holder that is too narrow.
- Handle equipment with clean, grease-free hands.
- Handle 50-liter capacity cylinders or larger using clean handling gloves and safety shoes.
- Do not handle a cylinder whose valve is not protected by a cap, except for cylinders with a capacity below 5 liters.
- Never lift a cylinder by its valve.
- Use specific connections or flexible connection components designed for Air.
- Use a pressure regulator with a flowmeter capable of withstanding a pressure of at least 1.5 times the cylinder's maximum service pressure (unless the valve has an integrated pressure reducer).
- For cylinder bundles, use only pressure gauges calibrated to at least 315 bar.
- Open the valve gradually.
- Never force the valve to open it, nor open it fully.
- Purge the cylinder outlet connection before attaching the pressure regulator to remove any dust. Keep the connections between the cylinder and the pressure regulator clean.
- Never subject the pressure regulator to repeated pressurizations.
- Never attempt to repair a defective valve.
- After use, close the cylinder valve, allow the pressure in the pressure regulator to decrease by leaving the flowmeter open, close the flowmeter, and then loosen (except in the case of integrated pressure regulators) the pressure regulator adjustment screw.
- In case of leakage, close the supply valve of the circuit with the leakage and verify that the emergency device is activated.
- Never transfer pressurized gas from one cylinder to another.
- If possible, ventilate the area of use, especially in confined spaces (e.g., vehicles).
Marketing Authorization Holder
AIR LIQUIDE Santé INTERNATIONAL
75 Quai d'Orsay
75007 Paris Cedex 07 (FRANCE)
Manufacturer responsible:
Air Liquide Healthcare España, S.L
C/ San Norberto, 23, 28021
Villaverde, Madrid - Spain
Air Liquide Medicinal S.A
Avenida Vasco Da Gama nº 7375, 4430-755
Avintes - Portugal
Date of latest revision of this leaflet: 04/2025