Conoxia 99.5% (v/v) medicinal cryogenic gas

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Conoxia 99.5 % (v/v) medicinal cryogenic gas

Oxygen

Read the entire leaflet carefully before you start using 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, ask your doctor, pharmacist or nurse.
• This medicine has been prescribed for you only, and you should not give it to other people, even if they have the same symptoms as you, because it may harm them.
• If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet.

Contents of the leaflet

1. What Conoxia 99.5% (v/v) medicinal cryogenic gas is and what it is used for
2. What you need to know before using Conoxia 99.5% (v/v) medicinal cryogenic gas
3. How to use Conoxia 99.5% (v/v) medicinal cryogenic gas
4. Possible side effects
5. How to store Conoxia 99.5% (v/v) medicinal cryogenic gas
6. Contents of the pack and other information

1. What Conoxia 99.5% (v/v) medicinal cryogenic gas is and what it is used for

Conoxia 99.5% (v/v) medicinal cryogenic gas is an inhalation gas supplied in liquid form contained in cryogenic vessels at cryogenic temperature (approximately -183°C).

It contains oxygen at a concentration equal to or greater than 99.5% v/v.

It contains no other excipients.

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

• Correction of oxygen deficiency of various origins requiring administration of oxygen at normal or increased pressure.
• Supplying anaesthesia and resuscitation ventilators.
• Administration via nebulizer of inhaled medications.

2. What you need to know before using Conoxia 99.5% (v/v) medicinal cryogenic gas

Do not use Conoxia 99.5% (v/v) medicinal cryogenic gas

This medicine must not be used under high pressure in cases of untreated lung collapse (untreated pneumothorax). A lung collapse is an accumulation of gas in the pleural cavity between the two lung membranes.

Inform your doctor if you have previously experienced a lung collapse.

Warnings and precautions

Consult your doctor, pharmacist, or nurse before starting to use Conoxia 99.5% (v/v) medicinal cryogenic gas.

You must inform your doctor if you suffer from chronic lung disease such as bronchitis, emphysema, or asthma, or if you are in a serious condition of oxygen deficiency.

Do not apply any greasy substances (e.g. vaseline, ointments, etc.) to the face due to the risk of inflammation with this medicine (see section 6).

In certain severe cases of oxygen deficiency, after 6 hours of exposure to 100% oxygen concentration, or after 24 hours of exposure to oxygen concentrations above 70%, pulmonary or neurological toxicity may occur (see sections 3 and 6). Therefore, high oxygen concentrations should be used for the shortest possible duration and monitored by arterial blood gas analysis, while simultaneously measuring the concentration of inhaled oxygen.

It is advisable to use, in any case, the lowest dose sufficient to maintain arterial partial pressure of oxygen (PaO₂) at 50–60 mmHg (i.e., 5.65–7.96 kPa). After 24 hours of exposure, it is recommended, as far as possible, to maintain an oxygen concentration below 45%.

Precautions for use

• This medicine must not be used in the presence of flammable materials: oils, lubricants, fabrics, wood, paper, plastic materials (see section 6).

• If oxygen is administered under high pressure (hyperbaric oxygen therapy), injuries may occur due to high pressure in body cavities containing air that communicate with the outside; compression and decompression must therefore be performed slowly (see section 4).

• If you are to receive high-pressure oxygen therapy (hyperbaric oxygen therapy), you must inform your doctor if any of the following conditions apply to you:

• If you have COPD (chronic obstructive pulmonary disease).

• If you have a lung disorder caused by loss of elasticity of lung tissue accompanied by severe breathing difficulty (pulmonary emphysema).

• If you have an upper respiratory tract infection (e.g., bronchitis).

• If you have chronic bronchitis.

• If you have recently undergone middle ear surgery.

• If you have ever had thoracic surgery.

• If you have uncontrolled high fever.

• If you have severe epilepsy.

• If you suffer from fear of enclosed spaces (claustrophobia).

• If you have previously experienced a lung collapse (accumulation of air or gas in the pleural cavity between the two lung membranes (pneumothorax)).

Children

In newborns, especially premature infants, eye damage (retinal abnormalities) may occur with certain oxygen concentrations.

In infants requiring oxygen concentrations above 30%, arterial partial pressure of oxygen (PaO₂) should be monitored regularly to ensure it does not exceed 100 mmHg (i.e., 13.3 kPa).

Use of Conoxia 99.5% (v/v) medicinal cryogenic gas with other medicines

Inform your doctor or pharmacist if you are currently using, have recently used, or might need to use any other medicines.

Oxygen toxicity may be increased by: corticosteroids, certain anticancer drugs, paraquat, sympathomimetics, X-rays, or in cases of hyperthyroidism or deficiency of vitamins C and E or glutathione deficiency.

Pregnancy and breastfeeding

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

Conoxia 99.5% (v/v) medicinal cryogenic gas has been widely used without any notable adverse effects.

Driving and using machines

There are no data available on the effects of Conoxia 99.5% (v/v) medicinal cryogenic gas on driving or operating machinery.

3. How to use Conoxia 99.5% (v/v) medicinal cryogenic gas.

Follow exactly the administration instructions for this medicine given by your doctor. In
case of doubt, consult your doctor again.

Your doctor will determine the correct dose of Conoxia 99.5% (v/v) medicinal cryogenic gas and will administer it using a system appropriate to your needs, which will ensure the delivery of the correct amount of Oxygen.

If you consider the effect of Conoxia 99.5% (v/v) medicinal cryogenic gas to be too strong or too weak, inform your doctor.

If you use more Conoxia 99.5% (v/v) medicinal cryogenic gas than you should

In case of overdose, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, indicating the medicine and the amount inhaled.

In the event of an overdose, the concentration of inhaled Oxygen should be reduced and symptomatic treatment is recommended.

4. Possible adverse effects

Like all medicines, Conoxia 99.5% (v/v) cryogenic gas may cause adverse effects, although not everyone will experience them.

In particular, in chronic respiratory failure, there is a possibility of apnea occurring. Inhalation of high concentrations of Oxygen may cause minor lung collapse.

Administration of Oxygen at high pressures may cause injury to the inner ear (potentially involving risk of rupture of the eardrum membrane), the nasal sinuses, and the lungs (potentially involving risk of pneumothorax).

Seizures have been reported after administration of 100% Oxygen for more than 6 hours, particularly when administered under high pressure.

Pulmonary injury may occur following administration of Oxygen concentrations exceeding 80%.

In newborns, especially if premature, exposure to high concentrations of Oxygen (FiO2 > 40%; PaO2 greater than 80 mmHg (i.e., 10.64 kPa)), or prolonged exposure (more than 10 days at FiO2 > 30%), carries a risk of retinopathy, which may appear between 3 and 6 weeks after treatment. This may regress spontaneously, but may also lead to retinal detachment or even permanent blindness.

Patients undergoing high-pressure Oxygen therapy in chambers may experience claustrophobic episodes.

If you experience any adverse effects, consult your doctor, pharmacist, or nurse, even if they are adverse effects not listed in this leaflet.

5. Storage of Conoxia 99.5% (v/v) medicinal cryogenic gas

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

Do not use this medicine after the expiry date stated on the label after {EXP}. The expiry date is the last day of the month indicated.

All regulations concerning the handling of pressurised containers must be followed. With regard to storage and transport, the following must be observed:

Storage of cryogenic containers:

Liquid containers must be stored dry and clean in a covered area, protected from weather conditions and wind, and designated for the storage of medicinal gases. They must also be protected from sources of heat or ignition, temperatures equal to or above 50°C, and from combustible materials.

Appropriate precautions must be taken to avoid shocks, impacts or falls.

Empty and full containers must be stored separately.

Storage of containers at home:

Containers must be installed in a location that protects them from the risks of impacts or falls, sources of heat or ignition, temperatures equal to or above 50°C, combustible materials, and adverse weather conditions.

Excessive storage must be avoided.

Transport of containers:

Containers must be transported using suitable equipment to protect them from the risk of impacts or falls.

During transport in vehicles, containers must be securely fastened. Continuous ventilation of the vehicle is mandatory, and smoking must be strictly prohibited.

6. Packaging contents and additional information

Composition of Conoxia 99.5% (v/v) medicinal cryogenic gas

• The active substance is: Oxygen (O2) at a concentration greater than or equal to 99.5% (v/v).
• It contains no excipients.

Appearance of the product and contents of the pack

Conoxia 99.5% (v/v) medicinal cryogenic gas is a gas for inhalation.

It is supplied in liquid form in mobile cryogenic containers of various capacities or in tanks.

The available pack sizes are:

• Domestic cryogenic containers: 21 litres, 31 litres, 41 litres.
• Mobile cryogenic containers: 160 litres, 210 litres and 600 litres.
• Tanks: 7000 litres, 10000 litres, 12100 litres, 17500 litres, 21000 litres, 22000 litres, 23000 litres and 23500 litres.

Not all pack sizes may be marketed.

Marketing Authorization Holder:

Linde GAS ESPAÑA, S.A.U.

C/ Camino de Liria, s/n,

P.O. Box number 25,

Puzol, 46530 Valencia, Spain

Manufacturer responsible for manufacturing:

LINDE GAS ESPAÑA, S.A.U.

P.I. Bañuelos, C/ Haití, 1; Alcalá de Henares (Madrid) – 28806 – Spain.

or

LINDE GAS ESPAÑA, S.A.U.

P.I. Can Pí de Vilaroch., Avd. Antonio Gaudí, 151; Rubí (Barcelona) – 08191 – Spain.

or

LINDE GAS ESPAÑA, S.A.U.

C/ Camino de Liria, s/n, Puzol – 46530, Valencia, Spain.

or

LINDE GAS ESPAÑA, S.A.U.

Polígono Industrial Ciudad de Transporte P-27.1 A 27.4, Jerez de la Frontera, 11407 Cádiz, Spain.

or

OXIGENO DE SAGUNTO, S.L.

Parque Industrial de Sagunto, Esq NE, Parcela AMS, C/ Acería s/n

46520 Puerto de Sagunto (Valencia), Spain

or

LINDE PORTUGAL, LDA

Loteamento Vilar do Senhor, Unidade J

Vila Nova da Telha, Portugal

or

Linde GAS ESPAÑA, S.A.U.

C/Hamburgo, 16, Pol El Bierzo

24400 Ponferrada, Spain.

or

MESSER IBERICA DE GASES, S.A.

Polígono Industrial El Morell s/n, El Morell, Tarragona 43760, Spain.

or

Linde GAS ESPAÑA, S.A.U.

C/ Pico Ocejón, 40; Torija 19190, Guadalajara, Spain.

Date of the most recent review of this leaflet: June 2009.

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es.

--------------------------------------------------------------------------------------------------------------------This information is intended for healthcare professionals only:

Instructions for use/handling

Do not smoke.

Do not bring near flame.

Do not grease.

In particular:

• Never introduce this gas into equipment suspected of containing combustible materials, especially those of a greasy nature.
• Never clean with combustible products, especially those of a greasy nature, either the equipment containing this gas, or the valves, seals, gaskets, or closure devices.
• Do not apply any greasy substances (vaseline, ointments, etc.) to the patient's face.
• Do not use aerosols (hair spray, deodorant, etc.) or solvents (alcohol, perfume, etc.) on or near the equipment.

To prevent any accidents, the following instructions must be strictly observed:

1. Check the equipment is in good condition before use.
2. Handle the equipment with clean hands, free from grease.
3. Use protective goggles and clean gloves suitable for this purpose.
4. Do not touch cold or frost-covered parts.
5. In case of cryogenic burn, rinse thoroughly with abundant water.
6. If clothing becomes saturated with oxygen, move away from the liquid oxygen source and from areas presenting a fire risk, and remove the clothing immediately.
7. Ventilate the area of use if possible, especially in confined spaces (vehicles, homes).
8. Open the valves of cryogenic containers gradually.
9. Never exceed the maximum service pressure.
10. Use oxygen-specific connectors.
11. Do not use intermediate adapters that allow connection of two incompatible devices.
12. Do not subject the hose to an excessively small bending radius. Do not leave the hose on the floor.
13. Provide overpressure safety devices in liquid oxygen circuits where liquid may accumulate between two valves.
14. In case of leakage, close the valve showing a leak and verify that the emergency device is activated.