OxÍgeno medicinal lÍqui… – инструкция – Испания

Инструкция по применению OxÍgeno medicinal lÍquido air liquide 99,5% v/v, gas criogÉnico medicinal en recipientes fijos

Introduction

Leaflet: information for the user

Oxígeno Medicinal Líquido Air Liquide 99.5% v/v, medicinal cryogenic gas in fixed containers

Read the entire leaflet carefully before starting to use this medicine, as it contains important information for you.

Keep this leaflet, as you may need to read it again.
If you have any doubts, consult your doctor, pharmacist or nurse.
This medicine has been prescribed only for you, and you must not give it to other people even if they have the same symptoms as you, as it may harm them.
If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are not listed in this leaflet. See section 4.

1. What is Oxígeno Medicinal Líquido Air Liquide and how it is used

2. What you need to know before starting to use Oxígeno Medicinal Líquido Air Liquide

3. How to use Oxígeno Medicinal Líquido Air Liquide

4. Possible adverse effects

5. Storage of Oxígeno Medicinal Líquido Air Liquide

6. Contents of the container and additional information

1. What is Liquid Medical Oxygen Air Liquide and for what it is used

Liquid Medical Oxygen Air Liquide is an inhalation gas that belongs to a group of medications called medicinal gases. It is packaged in cryogenic containers 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 a greater transport of oxygen to all body tissues.

Oxygen treatment is indicated in the following cases:

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

2. What you need to know before starting to use Medical Liquid Oxygen Air Liquide

No useOxygen Medical Liquid Air Liquide:

Oxygen at a pressure greater than atmospheric pressure (Hyperbaric Oxygen Therapy) should not be used in cases of untreated or undrained pneumothorax. A pneumothorax is due to the accumulation of air in the thoracic cavity between the two lung membranes. If you have ever had a pneumothorax, inform your doctor.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Oxygen Medical Liquid Air Liquide

Before starting oxygen therapy, you should know the following:

Oxygen can have harmful effects at high concentrations. This can cause lung damage (alveolar collapse, lung inflammation), making it difficult to supply oxygen to the blood.
If you have severe chronic obstructive pulmonary disease (COPD) that causes insufficient blood oxygenation, oxygen will be supplied at a low flow rate. Your doctor will adjust the appropriate oxygen therapy flow rate.
Adverse events may occur, such as eye damage in newborns, both full-term and premature. If your baby requires oxygen, your doctor will determine the appropriate oxygen concentration to administer.

Hyperbaric oxygen therapy requires precautions in the following cases:

Chronic obstructive pulmonary disease(COPD)
Pulmonary emphysema: a lung disorder due to loss of lung tissue elasticity accompanied by a severe lack of air
Upper respiratory tract infections
Uncontrolled asthma
Recent ear surgery
Recent thoracic surgery
Uncontrolled high fever
History of epilepsy or seizures
Claustrophobia (fear of enclosed spaces)
If you have ever had apneumothorax(accumulation of air or gas in the thoracic cavity between the two lung membranes)
Heart problems

Recommendations related to the increased risk of fire in the presence of oxygen:

Oxygen is an oxidizing agent and promotes combustion. Do not smoke or have open flames (e.g., pilot lights, kitchens, ovens, gas stoves, sparks, candles...) in rooms where Oxygen Medical Liquid Air Liquide is used, as this increases the risk of fire.

Do not smoke or use electronic cigarettes during the entire oxygen treatment.
Do not use toasters, hair dryers, or similar electrical equipment during oxygen treatment.
Do not apply greasy substances (e.g., oils, creams, ointments) to surfaces in contact with oxygen. Only water-based products should be used on hands and face or inside the nose while using oxygen.
The pressure regulator should be opened slowly and carefully to avoid the risk of fire.

Burns can occur due to accidental fires in the presence of oxygen.

Recommendations for caregivers:

Handle the cylinder with care. Ensure there is no risk of the cylinder falling and that it is not exposed to impacts.
Damage to the equipment can cause obstruction in the outlet and/or incorrect information displayed on the manometer regarding the remaining oxygen content and the supplied flow, leading to oxygen insufficiency or lack of administration.
Oxygen becomes liquid at around -183 ° C. There is a risk of burns at such low temperatures. Always wear protective gloves and glasses when working with medicinal liquid oxygen.

Children

In premature and newborn babies, oxygen therapy can cause eye damage (retinopathy of prematurity). Your doctor will determine the appropriate oxygen concentration to administer to ensure optimal treatment for your baby.

Other medications and Oxygen Medical Liquid Air Liquide

Inform your doctor or pharmacist if you are using, have used recently, or may need to use any other medication.

If you are using or have used bleomycin (to treat cancer), amiodarone (to treat heart diseases), nitrofurantoin (to treat an infection), inform your doctor before using oxygen, as there is a possibility of toxic effects on the lungs.

Previous lung damage caused by the pesticide Paraquat can worsen with oxygen administration. In cases of Paraquat poisoning, oxygen supply should be avoided as much as possible.

Pregnancy and breastfeeding

Oxygen Medical Liquid Air Liquide can be used during pregnancy, but only if necessary.

Oxygen Medical Liquid Air Liquide can be used during breastfeeding.

In all cases, inform your doctor if you are pregnant or suspect you may be.

If you are pregnant or breastfeeding, think you may be pregnant, or intend to become pregnant, consult your doctor or pharmacist before using this medication.

Driving and using machines

You can drive and use machines while using Oxygen Medical Liquid Air Liquide, provided your doctor considers you capable of doing so.

3. How to Use Liquid Medical Oxygen Air Liquide

Follow exactly the administration instructions of this medication as indicated by your doctor. In case of doubt, consult your doctor or pharmacist.

Your doctor will determine the correct dose ofMedical Liquid Oxygen Air Liquideand 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 have 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 have 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 who require assistance with breathing (assisted ventilation), oxygen should be administered at a dose that allows achieving a minimum oxygen concentration of 21%, which can reach up to 100%.

Administration form

The administration form is by inhalation.

In patients without 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 connecting assisted ventilation, or others.
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.

If you estimate that the action ofMedical Liquid Oxygen Air Liquideis too strong or too weak, inform your doctor.

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

If you use moreMedical Liquid Oxygen Air Liquidethan you should

If you have used moreMedical Liquid Oxygen Air Liquidethan you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 immediately.

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

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

In situations of vulnerability, excessive administration ofMedical Liquid Oxygen Air Liquidemay affect respiratory function and, in exceptional cases, cause neurological adverse effects that can lead to loss of consciousness in extreme situations.

Prolonged use ofMedical Liquid Oxygen Air Liquidein excess may cause respiratory pain, dry cough, and even respiratory difficulty. If these overdose symptoms appear, consult your doctor or go to the nearest hospital.

4. Possible Adverse Effects

Like all medications,this medicationcan produce adverse effects, although not all people will experience them.

Adverse effects generally appear at high concentrations and after prolonged treatment:

Very Frequent (can affect more than 1 in 10 people):

In newborns exposed to high concentrations of oxygen: eye damage, which can result in vision problems.

With hyperbaric treatment: ear pain, myopia, barotrauma (tissue or organ damage caused by a change in pressure).

Frequent (can affect up to 1 in 10 people):

With hyperbaric treatment: seizures.

Infrequent (can affect up to 1 in 100 people):

Pulmonary collapse

With hyperbaric treatment: rupture of the eardrum.

Rare (can affect up to 1 in 1,000 people):

With hyperbaric treatment: lack of air, abnormally low blood sugar levels in diabetic patients.

Unknown Frequency (cannot be estimated from available data):

Respiratory-related pain and dry cough, dryness in mucous membranes, local irritation, and mucous membrane inflammation.

With hyperbaric treatment: breathing difficulty, involuntary muscle contraction, dizziness, auditory alteration, acute serous otitis, nausea, abnormal behavior, peripheral vision decrease, visual changes, clouding of the lens (cataract).

Contact with liquid oxygen causes freezing injuries

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 it directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.notificaRAM.es. By reporting adverse effects, you can contribute to providing more information on the safety of this medication.

5. Conservation of Medical Liquid Oxygen Air Liquide 99.5% v/v, Medical Cryogenic Gas in Fixed Containers

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the packaging, after CAD. The expiration date is the last day of the month indicated.

All guidelines related to the handling of pressure containers must be followed.

- Fixed containers must be installed in clean, well-ventilated areas free from flammable materials. Storage of gases for medical use must be separate from gases for other uses.

- Fixed containers will be protected from ignition sources or heat and combustible materials.

- Fixed containers will be protected from shock risks, particularly filling, emptying, and safety elements.

- No parking should be allowed in the area where fixed containers are filled.

6. Contents of the packaging and additional information

Composition ofMedical Liquid Oxygen Air Liquide

The active ingredient is oxygen. The concentration of medical oxygen is equal to or greater than 99.5% v/v.
It does not contain other components.

Aspect of the product and contents of the packaging

Medical Liquid Oxygen Air Liquide is an inhalation gas that is transferred to fixed cryogenic containers. The cryogenic containers can be of the following volumes:

A container of type 800 contains 680 m3or 800 liters of gas

A container of type 1,200 contains 1,020 m3or 1,200 liters of gas

A container of type 3,000 contains 2,550 m3or 3,000 liters of gas

A container of type 5,000 contains 4,250 m3or 5,000 liters of gas

A container of type 7,500 contains 6,375 m3or 7,500 liters of gas

A container of type 10,000 contains 8,500 m3or 10,000 liters of gas

A container of type 15,000 contains 12,750 m3or 15,000 liters of gas

A container of type 20,000 contains 17,000 m3or 20,000 liters of gas

A container of type 32,000 contains 27,200 m3or 32,000 liters of gas

A container of type 50,000 contains 42,500 m3or 50,000 liters of gas

A container of type 63,000 contains 53,550 m3or 63,000 liters of gas

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

AIR LIQUIDESantéINTERNATIONAL – 75, Quai D`Orsay

75007 Paris (FRANCE)

Manufacturing responsible