Oxigeno medicinal liqui… – інструкція – Іспанія

Інструкція із застосування Oxigeno medicinal liquido air liquide 99,5% v/v gas criogenico medicinal en recipientes moviles

Introduction

Prospect: information for the user

OXÍGENO MEDICINAL LÍQUIDOAIR LIQUIDE99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers

Medical oxygen

Read this prospect carefully before starting to use this medication, as it contains important information for you.

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

1. What it isOxígeno Medicinal Líquido Air Liquide 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containersand for what it is used

2. What you need to know before starting to useOxígeno Líquido Air Liquide 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers

3. How to useOxígeno Medicinal Líquido Air Liquide 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers

4. Possible adverse effects

5. Storage ofOxígeno Medicinal Líquido Air Liquide 99.5% v/v medicinal cryogenic gas, in mobile cryogenic containers

6. Contents of the package and additional information

1. What is Liquid Medical Oxygen Air Liquide 99.5% v/v Medical Cryogenic Gas, in Mobile Cryogenic Containers and for what it is used

Liquid Medical Oxygen Air Liquide 99.5% v/v Medical Cryogenic Gas, in Mobile Cryogenic Containers, is a gas for inhalation that is packaged in liquid state in mobile cryogenic containers.

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

Correction of oxygen deficiency of different origins that require oxygen administration at normal or elevated pressure.
Supply of respirators in anesthesia – resuscitation.

Administration of inhalation medications via nebulizer.

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 deliver 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. The 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, the doctor will determine the appropriate oxygen concentration to administer.

Oxygen Hiperbaric therapy requires precautions in the following cases:

Chronic Obstructive Pulmonary Disease (COPD)(COPD)
Pulmonary Emphysema: a lung disorder due to the loss of elasticity of lung tissue accompanied by a severe lack of air
Upper Respiratory Tract Infections
Uncontrolled Asthma
Recent Middle 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) on 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.

Thermal burns may occur due to accidental fires in the presence of oxygen.

Recommendations for caregivers:

Handle the cylinder with care. Ensure there is no risk of cylinder fall 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 use protective gloves and glasses when working with liquid medical oxygen.

Children

In premature and newborn babies, oxygen therapy can cause eye damage (retinopathy of prematurity). The 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 disease), 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 may 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 pregnant.

If you are pregnant or breastfeeding, or suspect 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, as long as your doctor considers you capable of doing so.

3. How to Use Liquid Medical Oxygen Air Liquide

Follow exactly the administration instructions forthis medicationgiven by your doctor. In case of doubt, consult your doctor again.

Your doctor will determine the correct dose ofLiquid Medical Oxygen Air Liquide 99.5% v/v medicinal cryogenic gas, in cryogenic mobile containersand will administer it through an appropriate system for your needs that will ensure the supply of the correct amount of oxygen.

If you estimate that the action ofLiquid Medical Oxygen Air Liquide 99.5% v/v medicinal cryogenic gas, in cryogenic mobile containersis too strong or weak, inform your doctor.

If you use more Liquid Medical Oxygen Air Liquide than you should

If you have used moreLiquid Medical Oxygen Air Liquide 99.5% v/v medicinal cryogenic gas, in cryogenic mobile containersthan you should, consult your doctor, pharmacist, or call the Toxicological Information Service, phone 91 562 04 20 immediately.

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

In vulnerable situations, excessive administration ofLiquid Medical Oxygen Air Liquidemay affect respiratory function and, in exceptional cases, cause neurological adverse effects that may lead to loss of consciousness in extreme situations.

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

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

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: eardrum rupture.

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: difficulty breathing, 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 that does not appear 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 Mobile Cryogenic 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 label. The expiration date is the last day of the month indicated.

Particular precautions for storage:

Mobile cryogenic containers must be installed in clean, well-ventilated areas, free from flammable materials. Storage of medicinal gases must be separate from gases intended for other uses.
Mobile cryogenic containers will be protected from impacts and falls, particularly the filling, emptying, and safety elements, from ignition sources or heat, from temperatures above 50°C, and from combustible materials.
During the transportation of mobile cryogenic containers, potential risks caused by over-oxygenation must be monitored and controlled.

No parking should be done in the area where the mobile cryogenic containers are filled.

6. Contents of the packaging and additional information

Medical Oxygen Liquid Composition Air Liquide 99.5% v/v cryogenic medicinal gas, in mobile cryogenic containersin mobile cryogenic containers

The active ingredient is medical oxygen. The concentration of medical oxygen is greater than 99.5% v/v.

It does not contain other components.

Aspect of the product and contents of the packaging

Medical Oxygen Liquid Air Liquide 99.5% v/v cryogenic medicinal gas, in mobile cryogenic containersin mobile cryogenic containersis an inhalation gas that is packaged in liquid state in mobile cryogenic containers. The containers can be made of stainless steel with the following volumes:

Type of packaging	Size (liters)	Water capacity (liters)	Oxygen gas released at 1 Atmosphere and 15 °C (m3)	Product weight (kg) (kg)
Mobile cryogenic container of 29 liters	29	31	25	31
Mobile cryogenic container of 30 liters	30	31	25	34
Mobile cryogenic container of 31 liters	31	31	24	33
Mobile cryogenic container of 32 liters	32	33	26	35
Mobile cryogenic container of 41 liters	41	41	33	44
Mobile cryogenic container of 45 liters	45	47	37	50
Mobile cryogenic container of 46 liters	46	46	37	50
Mobile cryogenic container of 180 liters	180	196	156	212
Mobile cryogenic container of 240 liters	240	261	208	282
Mobile cryogenic container of 650 liters	650	707	563	765

Holder of the marketing authorization and responsible for manufacturing

Holder of the marketing authorization

AIR LIQUIDE Santé INTERNATIONAL – 75, Quai D`Orsay

75007 Paris (FRANCE)

Responsible for manufacturing