LIVOPAN 50%/50% Inhalation gas

Зміст інструкції

1. LIVOPAN GAS MEDICINAL COMPRESSED
   1. WHAT IS LIVOPAN AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE USING LIVOPAN
   3. HOW TO USE LIVOPAN
   4. POSSIBLE SIDE EFFECTS
   5. HOW TO STORE LIVOPAN
   6. CONTENT OF THE PACK AND OTHER INFORMATION

LIVOPAN GAS MEDICINAL COMPRESSED

50%/50 %
Nitrous oxide/Oxygen
Read this leaflet carefully before using this medicine as it contains important
information for you.

• Keep this leaflet, you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• This medicine has been prescribed for you only. Do not pass it on to others even if their symptoms are the same as yours because it could be harmful.
• If any side effects occur, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

• 1. What LIVOPAN is and what it is used for
• 2. What you need to know before using LIVOPAN
• 3. How to use LIVOPAN
• 4. Possible side effects
• 5. How to store LIVOPAN
• 6. Contents of the pack and other information

1. WHAT IS LIVOPAN AND WHAT IS IT USED FOR

Livopan contains a ready-to-use mixture composed of 50% nitrous oxide (Medicinal gas
“laughing gas”, N O) and 50% oxygen (Medical oxygen, O ) and must be administered via
inhalation.

The effects of Livopan
Nitrous oxide is present in the Livopan mixture at 50%. Nitrous oxide has an analgesic effect, reduces the sensation of pain and increases the pain threshold. Nitrous oxide also has an anxiolytic and slightly sedative action. These effects are determined by the action of nitrous oxide on the conduction of the nervous impulse.
The remaining 50% of the mixture consists of oxygen. Its content is about twice as much as that
present in the air, so as to guarantee a sufficient amount of oxygen in the inspired gas mixture.

What is Livopan used for
Livopan is used when a short-lasting and rapidly resolving analgesic effect is desired
and when moderate intensity and limited duration pain needs to be treated. Livopan produces
an analgesic effect after a few inhalations. The analgesic effect disappears a few minutes after
stopping the administration of the mixture.
Livopan can be used in adults and children from 1 month of age.

2. WHAT YOU NEED TO KNOW BEFORE USING LIVOPAN

Do not use Livopan and consult your doctor before using Livopan if you notice any of the following symptoms:

• Pneumothorax or embolism: if, due to a condition, or for any other reason, the presence of air in the pleural cavity or gas bubbles in the blood or other organs is suspected. For example, if you have performed underwater diving with diving equipment, or if you have undergone gas injections into the eye, for example for retinal detachment or similar problems, you may have gas bubbles in your blood. These gas bubbles could expand and create complications.
• Cardiac disorders:if you suffer from heart failure or cardiac function is severely impaired, the moderate relaxing effect of Livopan on the cardiac muscle may worsen its functionality.
• Central Nervous System disorders:in the presence of elevated intracranial pressure, for example in the case of a brain tumor or cerebral hemorrhage, the use of Livopan could further increase intracranial pressure and create complications.
• Vitamin deficiency:if a deficiency of vitamin B or folic acid has been diagnosed but not treated, the administration of Livopan could worsen the symptoms related to the deficiency of these vitamins.
• Ileus:in case of severe abdominal discomfort with symptoms related to ileus, as the use of Livopan could further increase the distended state of the intestine.
• Damage to the face and jaw may be difficult or risky when using the facial mask.

Warnings and precautions
Inform your doctor even in the presence of the following symptoms:

• Decreased level of consciousness or persistent state of confusion: inform your doctor if you do not feel well or feel that you are not fully conscious due to trauma or illness. This is important due to the sedative effects of nitrous oxide which is part of the mixture that makes up Livopan. There could be a risk of excessive sedation that could affect the natural protective reflex of the airways.
• Ear problems:for example, ear inflammation, as Livopan may increase pressure in the middle ear.
• Chronic Obstructive Pulmonary Disease (COPD), the use of oxygen can cause respiratory depression.
• Having or having had problems with drug dependence or substance abuse, there is a greater riskof developing dependence on nitrous oxide if you take it repeatedly. Your doctorwill decide when and if it is possible to undergo treatment with Livopan in your case.
• Vitamin deficiency:if you suspect a deficiency of vitamin B or folic acid, the use of Livopan could worsen the symptoms related to the deficiency of these vitamins.

In these situations your doctor may advise you on the correct use of Livopan.
Repeated or long-term use of nitrous oxide may increase the risk of vitamin B12 deficiency
which can lead to damage to the spinal cord and nervous system. Your doctor may
decide to perform blood tests before and after treatment to check the consequences of
a possible vitamin B12 deficiency.

Other medicines and Livopan
Inform your doctor or healthcare professional if you are taking, have recently taken or may
take any other medicine.

• Methotrexate for the treatment of, e.g., arthritis. Taking Livopan together with Methotrexate may affect the number of blood cells. If you are taking other drugs or substances that affect brain function, for example benzodiazepines (tranquilizers) or morphine-like drugs, you should inform your doctor as Livopan may enhance the effect of these drugs. Livopan in combination with other medicines that interact with the CNS activity may increase the risk of side effects.
• bleomycin (for the treatment of cancer), or amiodarone (for the treatment of heart disorders) before using Livopan because there is a possibility of toxic effects on the lungs due to the high concentrations of oxygen.
• nitrofurantoin or similar antibiotics (for the treatment of infections).

Livopan increases the side effects of these drugs.

Pregnancy and breastfeeding and fertility
If you are pregnant, suspect or are planning a pregnancy, or if you are breastfeeding with
breast milk, ask your doctor for advice before this medicine is given to you.
Livopan can be used during pregnancy if your doctor considers it clinically necessary. It can
also be used during labor. If used during labor, the baby should be observed for breathing difficulties (respiratory depression) and other adverse effects.
Livopan can be used during breastfeeding but not while breastfeeding
the newborn.

Driving and operating machinery
You should be aware that after taking Livopan you need to recover. Nitrous oxide
which is part of the mixture that makes up Livopan, disappears rapidly from the body after
a short administration. The effects on cognitive abilities can persist for several hours.
For safety reasons, you should avoid driving, operating machinery and performing complex tasks
until you have fully recovered from the effect of Livopan (at least 30 minutes).
Make sure your doctor informs you when you can resume driving.

3. HOW TO USE LIVOPAN

Livopan must always be administered in the presence of personnel familiar with this type of medication. Throughout the entire period of Livopan administration, you will be monitored by specialized personnel to ensure that administration occurs safely. At the end of the drug administration, you must be monitored by competent personnel until you have recovered from the effects of Livopan.
Take this medicine following the instructions of your doctor or healthcare professional exactly. If you have any doubts, consult your doctor or healthcare professional.
Your doctor or healthcare professional will explain how Livopan works, how to use it and what the effects of use are.
Livopan is usually administered via a facial mask, connected to a particular valve, which allows total control of the inspiratory flow by regulating it according to your respiratory needs. The valve only opens during the inspiratory phase. You may also take Livopan through a nasal mask.
Regardless of the type of mask used, you should always breathe normally into the mask.

Use in children
In children who are unable to understand and follow instructions, Livopan must be administered under the supervision of competent healthcare personnel, capable of controlling the administration and helping to keep the mask in the correct position. Livopan is administered with a constant flow of gas.
After finishing taking Livopan, you should rest until you feel you have fully regained consciousness.

Safety precautions

• It is strictly forbidden to smoke or use flames in the area where Livopan is used.
• Livopan must be used only for medical purposes.

Also refer to the instructions for storage and handling of cylinders (5. How to store Livopan).
If you take more Livopan than you should.
It is unlikely that you will be able to take a large amount of product, as you can personally regulate the delivery of gas and the gas mixture has a predetermined composition (50% nitrous oxide and 50% oxygen).
If you were to breathe at a rate higher than normal, and therefore receive more nitrous oxide than you would inhale by breathing normally, you may experience symptoms of fatigue and altered space-time perception. In this case, you should inform your doctor and stop Livopan therapy.
If you need further information about the pharmaceutical product, contact your doctor or healthcare professional.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everybody gets them.

Common Effects(may affect up to 1 in 10 people)
Dizziness, giddiness, euphoria, nausea, vomiting.

Uncommon Effects(may affect up to 1 in 100 people)
Asthenia (severe fatigue). If you use Livopan for a prolonged period, you may experience a
sensation of pressure in the middle ear, due to the fact that Livopan increases the pressure
in the middle ear.
Abdominal bloating, this is because Livopan slowly increases the volume of air present
in the intestine.

Not known(frequency cannot be estimated from available data)
Effects on nerve function, numbness and a feeling of weakness generally in the legs.
Effects on the bone marrow that can lead to anemia (decreased number of red blood cells) and
leukopenia (decreased number of white blood cells).
There may also be episodes of migraine or confusion at the end of administration.
Psychiatric effects such as psychosis, confusion and anxiety have been reported very rarely.
Respiratory depression
Dependence
Generalized seizures.

Reporting of side effects
If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. You can also report side effects directly through
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects you can help provide more information on the safety of
this medicine.

5. HOW TO STORE LIVOPAN

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is reported on the cylinder.
Do not store at temperatures below -5°C.
If you suspect that Livopan has been stored at too cold temperatures, place the cylinders in
a horizontal position at a temperature above +10°C for at least 48 hours before use.
Store the cylinder in a closed place reserved for the storage of medical gases.
Store the cylinder away from flammable materials.
Use only in well-ventilated areas.
Do not smoke and do not expose to high temperatures.
If there is a risk of fire, secure the cylinder. Keep the cylinder clean, dry and away from
contact with oil and grease.
Protect the cylinder from shocks and falls.
Store and transport the cylinders with the dispensing valve closed.
The vapours may cause dizziness and vertigo.

6. CONTENT OF THE PACK AND OTHER INFORMATION

What Livopan contains

• The active ingredients are: 50% nitrous oxide = exhilarating medicinal gas (chemical name: N O) and 50% oxygen = medicinal oxygen (chemical name: O )
• Livopan does not contain any other excipients or ingredients

Description of the appearance of Livopan and content of the pack.
Livopan is a colorless, odorless, tasteless gas and is dispensed in cylinders equipped with dispensing valves
capable of regulating its flow.
Pharmaceutical form: compressed medicinal gas.
The cylinder cap is painted white and blue (oxygen/nitrous oxide). The cylinder body is
white (medicinal gas).
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer:
Linde Sverige AB
Rättarvägen 3
16968 Solna
Sweden

Manufacturers:
Linde Gas AB
Baltzar von Platens gata 4-6
SE-74521 Enköping
Sweden
Linde France
16 avenue de la Saudrune
Zone industielle du Bois Vert
31 120 Portet sur Garonne
France
Linde Gaz Polska Sp. z o.o.
ul. Żwirowa 4
33-100 Tarnów
Pack size in liters 2 5 10
Poland
LINDE GAZ POLSKA Sp. z o. o.
Oddział w Warszawie
ul. Kasprowicza 132
01-949 Warszawa
Poland

Exclusive sales concessionaire:

LINDE MEDICALE S.r.L
Via Guido Rossa 3
20010 Arluno (MI)

• Freephone number: 800 985 597

Information provided by:

LINDE MEDICALE S.r.L
Via Guido Rossa 3
20004 Arluno (MI)

• Freephone number:

This medicinal product is authorised in the Member States of the European Economic Area under the following
denominations:
Austria LIVOPAN
Belgium RELIVOPAN
Czech Republic ENTONOX
Cyprus ENTONOX
Denmark LIVOPAN
Estonia ENTONOX
Finland LIVOPAN
Germany LIVOPAN
Greece ENTONOX
Hungary ENTONOX
Iceland LIVOPAN
Italy LIVOPAN
Latvia ENTONOX
Lithuania ENTONOX
Luxembourg RELIVOPAN
Netherlands RELIVOPAN
Norway LIVOPAN
Poland ENTONOX
Portugal LIVOPAN
Romania ENTONOX
Spain ENTONOX
Slovakia ENTONOX
Sweden LIVOPAN
This leaflet was last approved on:

Other sources of information
More detailed information on this medicinal product is available on the website of the Swedish
Medicines Agency: http://www.lakemedelsverket.se/.
The following information is intended exclusively for doctors or healthcare professionals.

Safety precautions
No adverse fetal effects have been observed in women exposed to chronic inhalation of nitrous oxide in the workplace during pregnancy if there is an adequate evacuation and
ventilation system.
Special precautions should be taken when working with nitrous oxide.
This product should be administered in accordance with Local Guidelines.
Livopan should only be used in well-ventilated areas and in places where there are tools to
evacuate any excess gas. Good ventilation and an evacuation system prevent excessive accumulation of this gas in the environment. High concentrations of this gas in the air could
create health problems for staff and those nearby. There are national guidelines that
establish the maximum concentration of nitrous oxide that can be present in the air and that
must not be exceeded. Exposure limits for personnel are often expressed in TWA (Time
Weight Average), which indicates the average exposure value over a working day, and in
STEL (Short-Term Exposure Limit), which indicates the short-term average exposure limit. To avoid
exposing staff health to risks, it is advisable not to exceed these values.
The possibility of abuse must be known.
Repeated administrations or exposures to nitrous oxide can lead to dependence. Caution must be exercised in professional operators with occupational exposure to nitrous
oxide.

• The valve should be opened slowly and carefully.
• Close all equipment used for dispensing if not in use and in the event of a fire.
• When in use, the cylinder must be secured to a suitable support.
• The gas cylinder must be replaced when the manometer indicator is positioned in the yellow reserve area.
• When a small amount of gas remains, the valve must be closed. A slight residual pressure should always remain to prevent possible contamination of the cylinder from the external environment. Close the valve after use. Depressurize all accessories used for administering the gas (regulator or connection).