DONOPA 50%/50% Ингаляционный газ

Содержание инструкции

1. DONOPA 50%/50% v/v compressed medicinal gas
   1. What is Donopa and what is it used for
   2. What you need to know before using Donopa
   3. How to use Donopa
   4. Possible side effects
   5. How to store Donopa
   6. Package contents and other information

DONOPA 50%/50% v/v compressed medicinal gas

Nitrous oxide / oxygen

Read this leaflet carefully before you start to use 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 pharmacist.
• This medicine has been prescribed for you only. Do not pass it on to others, even if their symptoms are the same as yours, as it could be harmful.
• If you get any side effects, even those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

Contents of this leaflet

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

1. What is Donopa and what is it used for

Donopa contains a ready-to-use mixture of nitrous oxide (N O) and oxygen (medical oxygen,
O ), each at 50% and must be used for inhalation of the mixture.
Donopa can be used in adults and children over 1 month of age.

The effects of Donopa
Nitrous oxide constitutes 50% of the gas mixture. Nitrous oxide has an analgesic effect, reduces the sensation of pain and increases the pain threshold. Nitrous oxide also has a relaxing and slightly calming effect. These effects are a consequence of the effect that nitrous oxide has on the substances transmitting signals in the nervous system.
The effect of Donopa is lesser in children under three years of age.
The oxygen concentration of 50%, about twice that of the air in the environment, ensures a safe oxygen content of the inspired gas.

Donopa must be used

• when a rapid onset and offset analgesic effect is desired and when the pain to be treated is of mild to moderate intensity and of short duration. Donopa produces analgesic effects after a few breaths and the analgesic effects decrease within a few minutes after stopping its use.
• for dental surgery in anxious patients.

2. What you need to know before using Donopa

Do not use Donopa:
Before using Donopa, inform your doctor if you experience any of the following signs/symptoms:

• Cavities containing gas or gas bubbles: when, following an illness or for any other reason, you suspect the presence of air in the chest cavity outside the lungs or gas bubbles in the blood or in an organ. For example, in case of immersion with diving equipment when gas bubbles may be present in the blood or in case of treatment involving an injection of gas into the eye, for example due to retinal detachment or other. These gas bubbles can expand and be dangerous.
• Heart disease:in case of heart failure or severely compromised heart function, as the slightly relaxing effect of nitrous oxide on the heart muscle may further worsen heart failure.
• Central nervous system injuries:in case of increased intracranial pressure, for example following a tumor or cerebral hemorrhage, as nitrous oxide may further increase intracranial pressure and be potentially dangerous.
• Vitamin deficiency:in case of diagnosis of vitamin B12 deficiency or untreated folic acid deficiency (including the early stages of pregnancy), as the use of nitrous oxide may worsen the symptoms caused by vitamin B12 and folic acid deficiency.
• Ileus (intestinal obstruction):in case of severe abdominal pain: in case of the presence of symptoms that may indicate an intestinal obstruction, as the use of Donopa may further increase the dilation of the intestine.

Warnings and precautions
Consult your doctor or pharmacist before using Donopa if:

• You are taking or have abused medications, as repeated administration of nitrous oxide can lead to a higher risk of developing dependence. Your doctor will determine if treatment with Donopa is possible in your case.

Repeated or prolonged use of nitrous oxide may increase the risk of vitamin
B12 deficiency, which can cause damage to the bone marrow and nervous system. Your doctor may initiate
hematological monitoring before and after treatment in order to assess the consequences of
possible vitamin B12 deficiency.
Also, inform your doctor if you experience any of the following signs/symptoms:

• Ear problems:for example, ear inflammation, as Donopa may

increase the pressure in the middle ear.

• Vitamin deficiency:in case of suspectedvitamin B or folic acid deficiency, as the use of nitrous oxide may worsen the symptoms caused by vitamin B and folic acid deficiency.
• The success rate is lower in children under 3 years of age.

You must breathe normally during inhalation.
The doctor will decide if Donopa is appropriate for use.

Other medicines and Donopa
Inform your doctor or pharmacist if you are taking, have recently taken, or may take
any other medicine.
If you are taking other medicines that affect the brain or brain functions, for example
benzodiazepines (tranquilizers) or morphine-like medicines, inform your doctor. Donopa may
increase the effects of these medicines. The use of Donopa, in combination with other sedatives or other
medicines that act on the central nervous system, increases the risk of side effects.
Also, inform your doctor if you are taking medicines that contain methotrexate (for example for
the treatment of rheumatoid arthritis), bleomycin (for the treatment of cancer), furadantin or
similar antibiotics (for the treatment of infections) or amiodarone (for the treatment of heart
disease). Donopa increases the side effects of these medicines.

Pregnancy, breastfeeding and fertility
Donopa may be used during pregnancy, if clinically necessary.
After a short administration of Donopa, it is not necessary to interrupt breastfeeding.
If you are pregnant, breastfeeding, suspect or are planning a pregnancy, ask
your doctor or pharmacist for advice before using this medicine.

Driving and operating machinery
If you have been given Donopa, without the addition of other sedative/analgesic medicines, for
safety reasons avoid driving, using machines or performing complicated tasks until you have
fully recovered (at least 30 minutes).
Ask your doctor if you can drive safely.

3. How to use Donopa

Donopa will always be administered in the presence of personnel experienced in the use of this type of
medicinal product. This will ensure that the administration of Donopa is suitable for you and that the equipment has been
prepared correctly. During the administration of Donopa you will be monitored to
ensure safe administration. At the end of the administration of Donopa you will be monitored by
competent personnel until you have recovered.
You must use this medicine exactly as recommended by your doctor.
The doctor will explain how to use Donopa, how it works and what effects result from its use. If you have
doubts, consult your doctor.
Donopa is generally inhaled through a mask applied to a special valve that
allows complete control of the gas flow through your breathing. The valve opens
only during inhalation. Donopa can also be administered through a so-called
nasal mask.
Regardless of the mask used, you must breathe normally through the mask.
After stopping the use of Donopa you should rest until you feel you have fully recovered
mental control.

Safety precautions

• Smoking and open flames are strictly prohibited in the areas where treatment with Donopa takes place.
• Donopa is intended exclusively for medicinal use.

If you use more Donopa than you should
It is very unlikely that you will be given too much gas, as you yourself regulate the
administration of the gas, moreover, the mixture is fixed (50% nitrous oxide and 50% of
oxygen).
If you breathe faster than normal, the amount of nitrous oxide administered will be
greater than if you breathe normally and you may feel tired and somewhat detached. In
this case, you should immediately inform the medical staff and stop the administration.
If you have any doubts about the use of this medicine, ask your doctor or pharmacist.

4. Possible side effects

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

Common(may affect up to 1 in 10 people)
Dizziness, lightheadedness, euphoria, nausea and vomiting

Uncommon(may affect up to 1 in 100 people)
Severe fatigue. Feeling of pressure in the middle ear if you use Donopa for a prolonged period. This happens because Donopa increases the pressure in the middle ear.
Abdominal bloating, because Donopa slightly increases the volume of intestinal gas.

Not known(frequency cannot be estimated from available data)
Effects on the bone marrow resulting in anemia.
Effects on nerve functions, sensation of numbness and weakness, usually in the legs.
This is because nitrous oxide affects the metabolism of vitamin B and folates, inhibiting an
enzyme: methionine synthase.
Abnormal movements may occur after hyperventilation (increased breathing rate during
inhalation).
Respiratory depression. Possibly headache.
Psychiatric effects, such as psychosis, confusion, anxiety, dependence.
Generalized epileptic 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 the website
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 Donopa

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 batch label of the
cylinder. The expiry date refers to the last day of that month.
Store between 0 °C and 50 °C. Do not freeze.
If it is suspected that Donopa has been stored at an excessively low temperature, it is
necessary to keep the cylinders in a horizontal position at a temperature above +10  C for
at least 48 hours before use.
Keep away from combustible material.
Contact with combustible material may cause fire.
Do not smoke or use flames near Donopa.
Do not expose to excessive heat.
In case of fire risk, move the cylinder to a safe place.
The cylinder must be stored clean, dry and free of oils and greases.
Store the cylinder in a closed place, intended exclusively for the storage of medicinal
gases.
During storage and transport the valves must be closed.
Ensure that the cylinder is not bumped and does not fall.
Inhalation of vapors may cause drowsiness and dizziness.

6. Package contents and other information

What Donopa contains

• The active ingredients are: nitrous oxide 50% (v/v) (chemical formula: N O) and oxygen 50% (v/v) = medical oxygen (chemical formula: O )
• Donopa does not contain any other components

Description of the appearance of Donopa and contents of the pack
Donopa is a colorless, odorless and tasteless gas, supplied in a cylinder with a valve for controlling the
gas flow. The cylinder may be made of steel or aluminum.
Pharmaceutical form: compressed medicinal gas
The top of the cylinder is marked with the colors white and blue (oxygen/nitrous oxide). The
body of the cylinder is white (medicinal gas).
Content in liters (135 bar) 2 2.7 5 10 15 20
Content in liters (185 bar) 2 5
Not all pack sizes may be marketed.

Marketing Authorisation Holder
SOL SpA
Via Borgazzi, 27
20900 Monza
Italy

Manufacturer
SOL France
ZI les Bethunes
8 Rue du Compas
95310 Saint Ouen l’Aumone
France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Austria: Donopa
Belgium: Antafil, 50%/50% v/v, compressed medicinal gas
Bulgaria:Donopa
Croatia:Donopa
Germany: Donopa
Greece: Donopa
Hungary: Donopa
Ireland: Donopa
Italy: Donopa
Luxembourg: Antafil, 50%/50% v/v, compressed medicinal gas
Netherlands: Donopa
Slovenia: Donopa
Spain: Donopa
RU: Donopa
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The following information is intended exclusively for healthcare professionals:
Safety precautions
Repeated administration or exposure to nitrous oxide may lead to dependence.
Healthcare professionals with professional exposure to nitrous oxide should be careful.
Nitrous oxide must be administered in accordance with local guidelines.
Donopa must only be used in well-ventilated areas equipped with special equipment for
evacuating excess gas. The use of an evacuation system and ensuring good
ventilation helps to avoid high concentrations of nitrous oxide in the ambient air.
High concentrations of nitrous oxide in the ambient air can cause adverse health effects on
staff or other people nearby. There are national guidelines on the concentration of nitrous oxide that must not be exceeded in the ambient air, the so-called “occupational exposure limits”, frequently indicated with TWA (time weighted average – time weighted average), i.e. the average value over a working day and STEL (short-term exposure limit – short-term exposure limit), i.e. the average value of a shorter exposure.
These values must not be exceeded to ensure that staff are not exposed to risks.

• The valve must be opened slowly and with caution.
• In case of fire or if not in use, deactivate the equipment.
• During use, the cylinder must be firmly secured, inserted into a suitable holder.
• Replace the gas cylinder when the pressure inside it has dropped to a point where the indicator on the valve is within the yellow area.
• If a small residue of gas remains in the cylinder, the valve must be kept closed. It is important that there is residual pressure inside the cylinder to prevent the entry of contaminants.
• After use, close the cylinder valve, tightening it by hand. Depressurize the regulator or connection.