Livopan

PACKAGE LEAFLET: INFORMATION FOR USE

LIVOPAN MEDICINAL GAS COMPRESSED

50%/50%
Nitrous oxide/Oxygen
Read this leaflet carefully before using this medicine because 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 give it to others, even if their symptoms are the same as yours, as it could be harmful.
• If you experience any adverse reaction, including those not listed in this leaflet, contact 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 LIVOPAN IS AND WHAT IT IS USED FOR

Livopan contains a ready-to-use mixture composed of 50% nitrous oxide (medical gas "laughing gas", N\ O) and 50% oxygen (medical oxygen, O\ ). It must be administered by inhalation.
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 anxiolytic and mildly sedative properties. These effects are due to the action of nitrous oxide on nerve impulse conduction.
The remaining 50% of the mixture consists of oxygen. Its content is approximately double that present in ambient air, thus ensuring an adequate supply of oxygen in the inhaled gas mixture.
What Livopan is used for
Livopan is used when a short-acting, rapidly reversible analgesic effect is desired, and when treating moderate-intensity pain of limited duration. Livopan produces an analgesic effect after a few inhalations. The analgesic effect disappears within a few minutes after stopping administration of the mixture.
Livopan can be used in adults and children from the age of 1 month.

2. WHAT YOU NEED TO KNOW BEFORE USING LIVOPAN

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

• Pneumothorax or embolism: if, due to a medical condition or for any other reason, air in the pleural cavity or gas bubbles in the blood or other organs are suspected. For example, if you have performed scuba diving with diving equipment, or if you have received intraocular gas injections, for instance for retinal detachment or similar conditions, you may have gas bubbles in your blood. These gas bubbles could expand and cause complications.
• Cardiac disorders: if you suffer from heart failure or severely impaired cardiac function, the mild relaxing effect of Livopan on the heart muscle may further worsen cardiac function.
• Central Nervous System disorders: in case of increased intracranial pressure, for example due to a brain tumor or cerebral hemorrhage, the use of Livopan could further increase intracranial pressure and lead to complications.
• Vitamin deficiency: if a deficiency in vitamin B or folic acid has been diagnosed but not treated, administration of Livopan may worsen symptoms related to the deficiency of these vitamins.
• Ileus: in case of severe abdominal disorder with symptoms suggestive of ileus, as the use of Livopan could further increase intestinal distension.
• Facial and jaw injuries may make the use of a facial mask difficult or risky.

Warnings and precautions
Inform your doctor also if you have any of the following symptoms:

• Reduced level of consciousness or persistent 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 Livopan mixture. There may be a risk of excessive sedation, which could impair the natural airway protective reflex.
• Ear problems: for example, ear inflammation, as Livopan could increase pressure in the middle ear.
• Chronic obstructive pulmonary disease (COPD): oxygen use may cause respiratory depression.
• History of drug dependence or medication abuse: there is an increased risk of developing dependence on nitrous oxide if used repeatedly. Your doctor will decide when and whether treatment with Livopan is possible in your case.
• Vitamin deficiency: if a deficiency in vitamin B or folic acid is suspected, the use of Livopan may worsen symptoms related to the deficiency of these vitamins.

In these situations, your doctor can 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 of the spinal cord and nervous system. Your doctor may decide to perform blood tests before and after treatment to monitor for possible vitamin B12 deficiency.
Other medicines and Livopan
Inform your doctor or healthcare professional if you are taking, have recently taken, or might take any other medicines.

• Methotrexate (used, for example, to treat arthritis). Taking Livopan together with methotrexate may affect blood cell counts. If you are taking other medicines or substances that affect brain function, such as benzodiazepines (tranquilizers) or morphine-like drugs, you must inform your doctor, as Livopan may enhance the effects of these drugs. Livopan, when used in combination with other medicines that interact with central nervous system (CNS) activity, may increase the risk of adverse effects.
• Bleomycin (used to treat cancer), or amiodarone (used to treat heart disorders), before using Livopan, because high oxygen concentrations may lead to potential lung toxicity.
• Nitrofurantoin or similar antibiotics (used to treat infections).

Livopan increases the side effects of these drugs.
Pregnancy, breastfeeding, and fertility
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or breastfeeding, consult your doctor before being given this medicine.
Livopan may be used during pregnancy if your doctor considers it clinically necessary. It may also be used during childbirth. If used during delivery, the newborn must be monitored for respiratory difficulties (respiratory depression) and other adverse effects.
Livopan may be used during breastfeeding, but not during actual breastfeeding of the newborn.
Driving and operating machinery
You should be aware that recovery is required after taking Livopan. The nitrous oxide contained in the Livopan mixture clears rapidly from the body after short administration. However, effects on cognitive abilities may persist for several hours. For safety reasons, you should avoid driving, operating machinery, or performing complex tasks until you have fully recovered from the effects of Livopan (at least 30 minutes).
Ensure your doctor informs you when you can safely resume driving.

3. HOW TO USE LIVOPAN

Livopan must always be administered in the presence of personnel familiar with this type of medicine. Throughout the entire administration period of Livopan, you will be monitored by specialized staff to ensure safe delivery. After completion of the drug administration, you must continue to be monitored by competent personnel until you have fully recovered from the effects of Livopan.

Take this medicine exactly as instructed by your doctor or healthcare provider. If you have any doubts, consult your doctor or healthcare provider.

Your doctor or healthcare provider will explain how Livopan works, how to use it, and what effects to expect.

Livopan is usually administered via a face mask connected to a special valve that allows complete control of the inspiratory flow, adjustable according to your respiratory needs. The valve opens only during the inspiratory phase. Livopan may also be administered through a nasal mask.

Regardless of the type of mask used, you must always breathe normally into the mask.

Use in children

In children unable to understand and follow instructions, Livopan must be administered under the supervision of competent healthcare personnel capable of monitoring the administration and assisting in keeping the mask properly positioned. Livopan is administered with a constant gas flow.

After completing the administration of Livopan, you should rest until you feel fully conscious again.

Safety precautions

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

Refer also 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 could inhale an excessive amount of the product, as you personally control the gas delivery and the gas mixture has a fixed composition (50% nitrous oxide and 50% oxygen).

If you breathe at a faster rate than normal, thereby receiving more nitrous oxide than you would during normal breathing, you may experience symptoms of fatigue and altered spatial-temporal perception. In this case, you should inform your doctor and stop treatment with Livopan.

If you need further information about the medicinal product, contact your doctor or healthcare provider.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
Common side effects (may affect up to 1 in 10 people):
Dizziness, vertigo, euphoria, nausea, vomiting.
Uncommon side effects (may affect up to 1 in 100 people):
Asthenia (severe fatigue). If Livopan is used for a prolonged period, you may experience a sensation of pressure in the middle ear, due to the fact that Livopan increases pressure in the middle ear.
Abdominal distension, because Livopan slowly increases the volume of air present in the intestine.
Unknown frequency (frequency cannot be estimated from available data):
Effects on nerve function, numbness and weakness, usually in the legs.
Effects on the bone marrow which may lead to anaemia (reduction in the number of red blood cells) and leucopenia (reduction in the 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 epileptic seizures.
Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, contact your doctor or healthcare professional. You can also report adverse reactions directly via
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting adverse reactions, 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 stated on the cylinder.
Do not store at temperatures below -5°C.
If it is suspected that Livopan has been stored at too low temperatures, place the cylinders
horizontally at a temperature above +10°C for at least 48 hours before use.
Store the cylinder in a closed area designated for the storage of medical gases.
Keep the cylinder away from combustible materials.
Use only in well-ventilated areas.
Do not smoke and avoid exposure to high temperatures.
In case of fire risk, move the cylinder to a safe place. Keep the cylinder clean, dry, and protected from
contact with oil and grease.
Protect the cylinder from impacts and falls.
Store and transport cylinders with the dispensing valve closed.
Vapours may cause dizziness and vertigo.

6. PACK CONTENT AND OTHER INFORMATION

What Livopan contains

• The active substances are: 50% nitrous oxide = medicinal laughing gas (chemical name: N₂O) and 50% oxygen = medicinal oxygen (chemical name: O₂)
• Livopan contains no other excipients or ingredients

Description of the appearance of Livopan and pack contents
Livopan is a colourless, odourless, tasteless gas supplied in cylinders equipped with outlet valves capable of regulating the flow.
Pharmaceutical form: compressed medicinal gas.
The cylinder shoulder is painted white and blue (oxygen/nitrous oxide). The cylinder body is white (medicinal gas).
Pack sizes in litres: 2, 5, 10
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 industrielle du Bois Vert
31 120 Portet sur Garonne
France
Linde Gaz Polska Sp. z o.o.
ul. Żwirowa 4
33-100 Tarnów
Poland
LINDE GAZ POLSKA Sp. z o.o.
Warsaw Branch
ul. Kasprowicza 132
01-949 Warszawa
Poland

Exclusive Sales Licensee:
LINDE MEDICALE S.r.L
Via Guido Rossa 3
20010 Arluno (MI)
Toll-free number: 800 985 597

Information provided by:
LINDE MEDICALE S.r.L
Via Guido Rossa 3
20010 Arluno (MI)
Toll-free number:

This medicinal product is authorised in the European Economic Area Member States under the following names:
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 Medical Products Agency: http://www.lakemedelsverket.se/.

The following information is intended for healthcare professionals only.

Safety information
No adverse fetal effects have been observed in women exposed occupationally to chronic inhalation of nitrous oxide during pregnancy, provided an adequate scavenging and ventilation system is in place.

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 locations equipped with devices to evacuate excess gas. Adequate ventilation and a scavenging system prevent excessive accumulation of this gas in the environment. High concentrations of this gas in the air may pose health risks to personnel and others nearby. National guidelines establish the maximum allowable concentration of nitrous oxide in the air, which must not be exceeded. Exposure limits for personnel are often expressed as TWA (Time-Weighted Average), indicating the average exposure level over a working day, and STEL (Short-Term Exposure Limit), indicating the short-term average exposure limit. To avoid health risks for personnel, these values should not be exceeded.

The potential for abuse must be recognised.
Repeated administration or exposure to nitrous oxide may lead to dependence. Caution is advised for healthcare professionals with occupational exposure to nitrous oxide.

• The valve should be opened slowly and carefully.
• Close all equipment used for gas delivery when not in use and in case of fire.
• When in use, the cylinder must be secured to an appropriate support.
• Replace the gas cylinder when the pressure gauge indicator enters the yellow reserve zone.
• When only a small amount of gas remains, close the valve. A slight residual pressure should always be maintained to prevent potential contamination of the cylinder from the external environment. Close the valve after use. Depressurise all accessories used for gas administration (regulator or connection).