NITROUS OXIDE MEDICINAL SOLGROUP 100% V/V LIQUEFIED MEDICINAL GAS

Introduction

Package Leaflet: Information for the User

Nitrous Oxide Solgroup 100% v/v, Liquid Medical Gas

Nitrous Oxide

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

• Keep this leaflet, you may need to read it again.
• If you have any further questions, ask your doctor, pharmacist, or nurse.
• If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the Package Leaflet

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

1. What is Nitrous Oxide Solgroup and what is it used for

Nitrous Oxide Solgroup is a colorless inhalation gas with a sweet smell (prepared for inhalation). The active substance is nitrous oxide, also known as "laughing gas". It belongs to the group of general anesthetics (narcotic agents).

Nitrous Oxide Solgroup is used in adults and in children from 1 month of age:

• combined with oxygen (50% nitrous oxide and 50% oxygen) to relieve mild to moderate pain, short-term and intermittent.
• mixed with a minimum of 21% oxygen as a basic anesthetic, in combination with other anesthetics.

2. What you need to know before you use Nitrous Oxide Solgroup

Do not useNitrous Oxide Solgroup:

• If you regularly or constantly inhale 100% medical oxygen
• If you have air trapped in a part of the body where possible expansion of the air could have very serious consequences, such as lung collapse (pneumothorax), respiratory difficulties such as emphysema or decompression sickness (decompression syndrome)
• If you have undergone coronary bypass surgery with or without extracorporeal circulation machine

• In patients with heart disease (e.g., heart failure or cardiac dysfunction)

• If you have facial injuries or a mandibular disorder
• In case of head injuries with consciousness disorders
• In case of severe gastric distension
• If suspected or observed increased intracranial pressure

• After a gas injection (e.g., SF6, C3F8) in the eye, it can cause an increase in eye volume and the possibility of causing blindness. (The doctor should not use Nitrous Oxide Solgroup until sufficient time has passed).
• If you have been diagnosed with vitamin B12 or folic acid deficiency (even during the early stages of pregnancy), but have not followed any treatment for this, as the use of Nitrous Oxide Solgroup can worsen the symptoms caused by vitamin B12 and folic acid deficiency.

Warnings and precautions

Consult your doctor or pharmacist before starting to use Nitrous Oxide Solgroup:

• If you have or have had a tendency to abuse drugs/medicines, as there is a higher risk of developing dependence on nitrous oxide if it is administered repeatedly. Your doctor will decide if treatment with Nitrous Oxide Solgroup is suitable for you.
• Repeated or prolonged use of nitrous oxide may increase the risk of suffering from vitamin B12 deficiency, which could affect the bone marrow or nervous system. Your doctor may prescribe blood tests before and after treatment to assess the consequences of a possible vitamin B12 deficiency.

• If you suffer from vitamin B12 deficiency, such as in people with pernicious anemia (malignant form of anemia) or Crohn's disease (chronic enteric disease) or in vegetarians.
• If you suffer from heart failure (if your heart does not function properly).
• If you suffer from severe hypotension as a result of shock or cardiac arrest.
• If you suffer from sickle cell anemia (a specific blood disease in which red blood cells have an abnormal shape).
• If you have been administered opioid analgesia during childbirth (the combination of this type of medication with Nitrous Oxide Solgroup can cause loss of consciousness).
• After an injection in the eye (with another agent), sufficient time must pass before administering Nitrous Oxide Solgroup, as otherwise, there is a risk of eye problems (including blindness).

• Due to its nitrous oxide content, Nitrous Oxide Solgroup can increase pressure in the middle ear and other air-filled cavities.

• When benzodiazepines are administered at the same time (a specific group of medications with tranquilizing, soporific, and/or muscle relaxant properties), as loss of consciousness may occur.
• If you have received treatment with bleomycin (a medication administered in cancer treatment).

Children and adolescents

Do not administer this medication to neonates (at term or premature).

Using Nitrous Oxide Solgroup with other medications

Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medication.

NOTE: The following warnings also apply to the use of medications before or after using Nitrous Oxide Solgroup.

• Narcotic medications potentiate the activity of Nitrous Oxide Solgroup.
• Medications containing morphine increase the analgesic and sedative effects of Nitrous Oxide Solgroup.
• Benzodiazepines and barbiturates (a specific group of medications with tranquilizing, soporific, and/or muscle relaxant properties) increase the effect of Nitrous Oxide Solgroup, and the combination of these medications with Nitrous Oxide Solgroup can cause loss of consciousness.
• The action of certain muscle relaxants (such as pancuronium, vecuronium) increases with Nitrous Oxide Solgroup.
• The damage caused by sodium nitroprusside (a medication used in the treatment of high blood pressure) and methotrexate (a medication used in cancer treatment) increases because the action of vitamin B12 predominates over Nitrous Oxide Solgroup.
• The damage caused by bleomycin (a medication used in cancer treatment) in the lungs may be increased if oxygen administration is increased (as occurs in treatment with Nitrous Oxide Solgroup).

Using Nitrous Oxide Solgroup with food, drinks, and alcohol

If Nitrous Oxide Solgroup is used as a component of an anesthetic, do not eat or drink anything in the 6 hours prior to general anesthesia, as Nitrous Oxide Solgroup can cause nausea or vomiting (see section 4 "Possible side effects").

Pregnancy, breastfeeding, and fertility

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or pharmacist for advice before using this medication.

Pregnancy

Some data have indicated that short-term use of Nitrous Oxide Solgroup does not pose a greater risk of congenital malformations. In isolated cases, Nitrous Oxide Solgroup may cause respiratory problems in newborns. Nitrous Oxide Solgroup should only be used during pregnancy if strictly necessary. Frequent or prolonged use should be avoided.

Breastfeeding

It is unknown whether nitrous oxide is excreted in breast milk. It is not necessary to interrupt breastfeeding after a short period of administration.

Fertility

There are no relevant data in humans regarding the effects of nitrous oxide on fertility. Animal studies indicate that female and male fertility may be affected by exposure to low concentrations (≤1%).

Driving and using machines

• Do not drive or use any tools or machines for 24 hours after administration of Nitrous Oxide Solgroup combined with anesthetic medications, as Nitrous Oxide Solgroup has a significant effect on the ability to drive and operate machines.
• Be careful after short-term administration of nitrous oxide for pain relief. Do not drive or use machines until the side effects have disappeared and you have regained the level of alertness you had before treatment.

3. How to use Nitrous Oxide Solgroup

Inhalation use.

Your doctor will administer Nitrous Oxide Solgroup and set the correct dose.

For short-term use for pain relief

When administered for pain relief, Nitrous Oxide Solgroup is only used in combination with the same proportion of oxygen (50% nitrous oxide and 50% oxygen).

The analgesic effect occurs after 4-5 inhalations, producing maximum pain relief after 2-3 minutes. Administration of Nitrous Oxide Solgroup should continue throughout the painful procedure or for as long as the analgesic effect is desired.

After discontinuation of administration/inhalation, the effects disappear rapidly within a few minutes.

The maximum administration period should not exceed 1 hour continuously per day.

This treatment should not be repeated for more than 15 consecutive days.

Depending on the individual patient's response to pain relief, additional analgesics may be required.

For use in combination with anesthetic medications

When used in combination with anesthetic medications, Nitrous Oxide Solgroup is only administered mixed with a minimum of 21% oxygen. Nitrous oxide alone cannot cause anesthesia. Combining anesthetic medications with Nitrous Oxide Solgroup means that less of other anesthetic medications are needed. The effect is usually observed within 2 to 5 minutes.

Instructions for use of Nitrous Oxide Solgroup

Nitrous oxide (medicinal) will be administered by inhalation and a facial mask, mouthpiece, or nasal cannulas should be used. The mask or mouthpiece is connected to the nitrous oxide (medicinal) through a suitable medical device. The device should be handled as described by the manufacturer. These systems should only be used to administer nitrous oxide under the direct supervision and care of medical personnel with adequate training in well-ventilated areas, to prevent exhaled Nitrous Oxide Solgroup from entering the ambient air.

If you use more Nitrous Oxide Solgroup than you should

The consequences of an overdose of nitrous oxide medicinal cause acute oxygen deficiency. In case of overdose, administration of nitrous oxide medicinal should be stopped immediately and the patient should be ventilated with air or oxygen until the oxygen concentration in the blood returns to normal levels.

If you stop using Nitrous Oxide Solgroup

If you stop using nitrous oxide medicinal and medical oxygen, it can cause oxygen deficiency. To avoid this, the patient can be temporarily ventilated with 100% oxygen.

If you have any other questions about the use of this medication, ask your doctor, pharmacist, or nurse.

4. Possible side effects

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

The following side effects have been classified by organs. There are not many data on the frequency of side effects, but these occur more frequently with a higher dose and/or a longer administration period. Nausea and vomiting are the most common side effects.

Blood and lymphatic system disorders

• Megaloblastic anemia (a type of anemia caused by vitamin B12 deficiency caused by nitrous oxide)

• Granulocytopenia (complete deficiency of a type of blood cells)

Psychiatric disorders

• Psychosis (severe mental illnesses in which control of behavior and actions is impaired), confusion, and headache, although it also causes reduced anxiety and improved mood.
• Addiction (frequency not known).

Nervous system disorders

• Decreased circulation in the brain and decreased glucose consumption by the brain.
• Psychotropic effects may occur, even without administering another anesthetic medication.
• Neurological effects: spinal cord disorders, neuropathy, paresthesias (sensations such as pins and needles) throughout the body, myeloneuropathy, epilepsy, generalized convulsions (frequency not known), sedation, dizziness, increased intracranial pressure, symptoms of paralysis in the legs with muscle cramps.
• Effects on nervous functions, sensation of numbness and weakness, especially in the legs (frequency not known).
• Decrease and/or intense increase in body temperature.

Eye disorders

Slowed eye movements.

Temporary increase in pressure and/or volume in the eye if Nitrous Oxide Solgroup is administered after injection of a gas-generating medication in the eye.

Ear and labyrinth disorders

Middle ear damage and eardrum rupture.

Cardiac disorders

• Cardiac arrhythmia
• Heart failure
• Increased blood pressure in the lungs
• Hypotension in the body

Respiratory, thoracic, and mediastinal disorders

• Respiratory depression
• Air in the chest cavity
• Subcutaneous emphysema and symptoms similar to a respiratory infection.

Gastrointestinal disorders

• Nausea
• Vomiting
• Temporary increase in pressure and/or volume in the intestines and abdominal cavity

Hepatobiliary and pancreatic disorders

• Jaundice
• Increased concentration of liver enzymes.

Reporting of side effects

If you experience any side effects, talk to your doctor, pharmacist, or nurse, even if it is possible side effects not listed in this leaflet. You can also report them directly through the Spanish Medicines Agency's online reporting system: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medication.

5. Storage of Nitrous Oxide Solgroup

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

Qualified personnel will be responsible for storing Nitrous Oxide Solgroup according to the manufacturer's instructions and applicable regulations.

Do not use this medication after the expiration date stated on the label, after {CAD.}. The expiration date is the last day of the month indicated.

See complete information on special storage conditions at the end of the leaflet: Information intended only for healthcare professionals.

6. Container Content and Additional Information

Composition of Nitrous Oxide Medicinal Solgroup

• The active ingredient is nitrous oxide (dinitrogen monoxide).
• Nitrous Oxide Medicinal Solgroup does not contain any other components.

Appearance of the Product and Container Content

• Nitrous Oxide Medicinal Solgroup is an inhalation gas (preparation for inhalation) and is packaged in a liquid form in pressurized gas cylinders. The cylinders are color-coded: the body is pure white (RAL 9010) and the shoulder is gentian blue (RAL 5010).
• The following table shows the content of various gas cylinders (in liters) and the corresponding amount of kilograms of nitrous oxide gas at a pressure of 45 bar (at 15°C).

Only some package sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

SOL FRANCE SUCURSAL EN ESPAÑA

Calle Yeso, num. 2

28500 Arganda del Rey - (Madrid)

Spain

Manufacturer:

SOL Nederland B.V.

Swaardvenstraat 11

5048 AV Tilburg

Netherlands

or

SOL B S.r.l.

Zoning Ouest 15

7860 Lessines

Belgium

or

SOL S.p.A.

Via Acquaviva 4

26100 Cremona

Italy

or

SOL France S.A.S.

ZI des Béthunes

8 Rue du Compas

95310 Saint Ouen L'Aumone

France

or

SOL Hellas S.A.

Thesi Stefani, ASPROPYRGOS ATTIKI,

GR-193 00 Greece

Further information on this medicinal product can be obtained from the local representative of the marketing authorization holder:

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Belgium: Protoxyde d’azote Médicinal SOL 100 % v/v, gaz médicinal liquéfié

Bulgaria: ?????????? ???????? ????? SOL 100 % v/v, ??????? ??????????

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Luxembourg: Protoxyde d’azote Médicinal SOL 100 % v/v, gaz médicinal liquéfié

Slovenia: Medicinski didušikov oksid SOL 100 % medicinski plin, utekocinjen

Slovakia: Medicinálny oxid dusný SOL 100%, medicinálny plyn skvapalnený

Spain: Óxido nitroso medicinal SOLGROUP, 100% v/v, gas licuado medicinal

Greece: Φαρμακευτικ? Πρωτοξε?διο του Αζ?του SOL, 100% v/v, Ιατρικ? α?ριο, υγροποιημ?νο

Hungary: SOL Orvosi Dinitrogén-oxid, 100% v/v, Cseppfolyósított orvosi gáz

Ireland: Nitrous oxide medicinal SOL, 100%v/v, medicinal gas, liquefied

Netherlands: Distikstofoxide Medicinaal SOL, medicinaal gas, vloeibaar gemaakt 100% v/v

Czech Republic: Medicinální oxid dusný SOL 100%, medicinální plyn, zkapalnený

Romania: Protoxid de azot SOL 100% gaz medicinal lichefiat

United Kingdom: Nitrous oxide 100%v/v medicinal gas, liquefied

Date of the Last Revision of this Leaflet:

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The following information is intended for healthcare professionals only:

Safety Guidelines

Administration or repeated exposure to nitrous oxide may cause addiction. Healthcare professionals with occupational exposure to nitrous oxide should take appropriate precautions.

Precautions and Special Storage Conditions

• Store gas cylinders at a temperature between -20°C and +65°C.
• Store gas cylinders in a well-ventilated area suitable for the storage of medicinal gases.
• Keep gas cylinders away from flammable products.
• Avoid any contact with oil, grease, or similar substances.
• Keep gas cylinders upright, except for those with convex bases, which should be stored lying down or in a drawer.
• Protect gas cylinders from falls and impacts by securing them in place or storing them in a cage.
• Gas cylinders containing a different type of gas or composition should be stored separately.
• Store full and empty gas cylinders separately.
• Do not store gas cylinders near a heat source.
• Store gas cylinders covered and protected from atmospheric conditions.
• The valves of the gas cylinders for nitrous oxide are fitted with a rupture disc to prevent the cylinder from bursting if the internal pressure is too high. The rupture disc may fail if the temperature is too high. The entire contents of the cylinder will be released. In this case, do not enter the storage area and ventilate it until it is clear for use by a professional.

Instructions for Use, Processing, and Disposal

Follow the instructions of your supplier, and in particular the following:

• Nitrous oxide should only be administered after the corresponding pressure and outlet regulation has been carried out between the cylinder and the patient.
• Before opening the valve of the cylinder, the cylinder must be in a vertical position and must be kept in a vertical position during administration.
• The administration of nitrous oxide will be carried out together with the administration of oxygen through a safe mixer; the pressure of nitrous oxide in the lines must always be lower than the pressure of oxygen.
• If a variable mixer is used, it is recommended to monitor it with an oxygen analyzer.
• The gas cylinder must not be used if visible damage is observed or possible damage is suspected, or if it has been exposed to high temperatures.
• Any contact with oil, grease, or similar substances must be avoided.
• Only equipment suitable for the specific type of gas and gas cylinder will be used.
• Pliers, forceps, or other instruments must not be used to open or close the valve of the cylinder, as this may damage it.
• The type of packaging must not be modified.
• In case of loss, the valve of the gas cylinder should be closed immediately if it can be handled safely. If it is not possible to close it, the gas cylinder should be taken to a safe outdoor location and allowed to empty.
• The valves of empty gas cylinders should be closed.
• It is not permitted to extract the compressed gas with a siphon.
• The facilities used, with central storage, distribution networks, piping systems, terminal units, and connections, must comply with current regulations.
• Nitrous oxide can cause the immediate ignition of sparking or flammable material, so smoking or bringing a flame near the gas cylinder is prohibited.
• Nitrous oxide is a non-toxic, non-flammable gas that can cause fire. It can form explosive mixtures in combination with flammable anesthetic gas or vapor, even in the absence of oxygen.
• Once empty, return the gas cylinders to the supplier.