Serynox 50%/50% medicinal compressed gas
SpainTable of Contents
Package leaflet: Information for the user
Introduction
Package leaflet: information for the user
Serynox 50% / 50% medicinal compressed gas
nitrous oxide/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, consult your doctor, pharmacist or nurse.
- If you experience any adverse effects, consult your doctor, pharmacist or nurse, even if they are adverse effects not listed in this leaflet. See section 4.
Leaflet contents
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What Serynox is and what it is used for
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What you need to know before using Serynox
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How to use Serynox
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Possible side effects
- How to store Serynox
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Contents of the pack and other information
1. What Serynox is and what it is used for
Serynox contains a mixture of two medicinal gases:
- 50% nitrous oxide ("medicinal laughing gas"),
- 50% oxygen (medicinal oxygen).
It is used by inhaling the gas mixture. At this concentration, Serynox has no narcotic (anaesthetic) effect.
Serynox belongs to the group of nitrous oxide combinations.
Serynox can be used in adults, adolescents, and children older than 1 month of age.
Serynox works by reducing the sensation of pain and increasing patient relaxation during:
- short-term analgesia for procedures or situations involving mild to moderate pain intensity, and sedation during dental surgery, when rapid onset and offset of analgesia are required.
2. What you need to know before using Serynox
Do not use Serynox
- if a gas has been introduced into your eye during eye surgery, always inform your doctor so they can ensure administration will not cause serious postoperative complications due to increased intraocular pressure;
- if your condition requires administration of 100% oxygen;
- in case of excessive pressure in the head (increased intracranial pressure);
- in case of altered consciousness (consciousness is not fully normal);
- in case of known untreated deficiency of vitamin B12 or folic acid;
- in case of recent neurological disorders of unknown cause;
- in patients with heart failure or cardiac dysfunction (e.g., following cardiac surgery).
When Serynox is inhaled, gaseous bubbles and air-filled cavities in the body may expand and cause serious harm. Therefore, Serynox must not be used in the following cases:
- head trauma
- facial or jaw trauma
- accumulation of air between the lungs and the chest cavity (pneumothorax)
- lung alveolar disease causing breathing difficulties (severe emphysema)
- formation of air bubbles in the bloodstream (gas embolism)
- deep-sea diving with risk of decompression sickness
- brain radiography
- surgery on the middle or inner ear or paranasal sinuses
- presence of air in the abdomen causing severe abdominal discomfort
- having received spinal anesthesia to relieve pain from the hips downward (epidural anesthesia) during which air was injected
Warnings and precautions
Consult your doctor before starting to use Serynox.
Serynox must be administered by trained personnel. However, self-administration under medical supervision is preferred to assess the patient's level of consciousness. NEVER handle the Serynox cartridge yourself.
Areas where Serynox is used must be adequately ventilated and/or equipped with an extraction system to keep ambient nitrous oxide concentrations as low as possible.
You must breathe normally while inhaling Serynox.
Use in neonates is not recommended.
Possible adverse effects, especially respiratory depression, should be monitored in newborns when Serynox is administered to the mother during childbirth.
Prolonged or repeated administration of Serynox may lead to abuse and dependence.
With repeated or prolonged administration of Serynox, vitamin B12 may lose its effectiveness in the body. Your doctor may need to prescribe vitamin B12.
Consult your doctor in the following situations, as there is a risk of vitamin B12 deficiency:
- if you have anemia, a specific type of stomach lining inflammation (atrophic gastritis), or a brain disease;
- if you are vegetarian;
- if you are alcoholic.
If you or your children have an acute ear infection, inform your doctor.
Use of Serynox with other medicines
Tell your doctor or pharmacist if you are taking, have recently taken, or might need to take any other medicines.
Inform your doctor if:
- you have received an injection of an ophthalmic gas during eye surgery, as there is a risk of postoperative complications if intraocular pressure rises too much;
- you are taking medicines that act on the central nervous system (such as morphine derivatives, benzodiazepines, and other psychotropic medicines), as they may enhance hypnotic effects;
- you are taking vitamin B12/folic acid, as vitamin B12 may lose its effectiveness due to Serynox.
Serynox may enhance methotrexate toxicity by interfering with folate metabolism.
Pulmonary toxicity associated with active substances such as bleomycin, amiodarone, nitrofurantoin, and similar antibiotics may be exacerbated by inhalation of high oxygen concentrations.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to become pregnant, consult your doctor or pharmacist before using this medicine.
Serynox may be used during pregnancy when clinically indicated.
If used close to delivery, adverse reactions in the newborn should be monitored.
After short-term administration of Serynox, breastfeeding does not need to be interrupted.
Driving and use of machines
Serynox has effects on perception and motor-related behavior (cognitive and psychomotor functions).
After administration of Serynox, you will be monitored until all effects have disappeared and until you have regained the same level of alertness as before administration. After receiving nitrous oxide, driving, operating machinery, or performing other activities requiring adequate psychomotor function is not recommended for a reasonable period of time following exposure.
3. How to use Serynox
Dosage
Serynox must only be administered by personnel familiar with this type of medication. Your doctor will explain how to use Serynox, how it works, and what effects its use may produce. For certain procedures, you may be asked to hold the equipment for gas administration. This will allow you to self-administer the amount of gas.
Throughout the time you are using Serynox, both you and the administration of the medication will be monitored to ensure it is being administered safely.
Administration of Serynox must be discontinued if verbal contact is lost.
Maximum analgesic effect is achieved after at least 3 minutes.
Method of administration
Serynox is administered by inhalation.
Serynox is a mixture of two medicinal gases that you will inhale through a face mask connected to an appropriate device.
While inhaling Serynox, you must breathe normally.
When you stop using Serynox, the mask will be removed and you should rest and recover until you feel mentally recovered.
Duration of use
The use of Serynox depends on the duration of the procedure and normally should not exceed one 60-minute inhalation per day. Repeated administration of Serynox should not exceed 15 days.
If you use more Serynox than you should
It is highly unlikely that you will receive too much gas, as you can control the amount of gas you inhale through the mask and you are closely monitored.
If you breathe faster than normal and therefore receive more nitrous oxide than you would under normal breathing, you may feel noticeably tired and somewhat disconnected from your surroundings.
In such circumstances, you must immediately inform the medical staff and stop administration.
If your skin turns blue (cyanosis) during the use of Serynox, medical staff will immediately discontinue treatment. If cyanosis does not rapidly improve, you will be ventilated with air using a manual resuscitation bag or with oxygen.
In case of overdose or accidental ingestion, contact your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.
If you stop treatment with Serynox
The analgesic effect disappears immediately after Serynox administration is stopped, with no irreversible effects.
If you have any further questions about the use of this medicine, ask your doctor or pharmacist.
4. Possible adverse effects
Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.
The following adverse effects may occur during treatment and usually disappear within a few minutes after stopping inhalation of the mixture:
Common: may affect up to 1 in 10 people
- dizziness
- lightheadedness
- nausea
- vomiting
Uncommon: may affect up to 1 in 100 people
- tingling sensation (paresthesia)
- deep sedation (somnolence)
- hallucinations
- anxiety
- agitation
- euphoria
- dreams
Frequency not known: cannot be estimated from the available data
- headache
- convulsion
- increased intracranial pressure (see section 2, Do not use Serynox)
- ear pain
- psychosis
- confusion
- disorientation
- respiratory depression (in neonates during childbirth)
- severe visual impairment (caused by expansion of intraocular gas, see section 2, Do not use Serynox)
After prolonged and repeated use of Serynox
Frequency not known: cannot be estimated from the available data
Following increased breathing during inhalation (hyperventilation), abnormal movements may occur.
Neurological disorders such as spinal cord diseases (myeloneuropathies).
Reduction in the number of red blood cells, accompanied by a decrease in the number of white blood cells (megaloblastic anemia with leucopenia).
Abuse and dependence.
Vitamin B12 deficiency (see section 2, Do not use Serynox, Warnings and precautions, and Use of Serynox with other medicines).
Reporting of adverse effects
If you experience any type of adverse effect, consult your doctor, pharmacist, or nurse, even if it is a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.
5. Storage of Serynox
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the gas cylinder after EXP.
Storage of gas cylinders
Store the gas cylinders as indicated below:
Gas cylinders must be securely stored in an UPRIGHT POSITION (full cylinders in gas storage areas, full cylinders in use, full cylinders for transport within healthcare facilities and vehicles, storage of empty cylinders).
This medicine does not require any special storage conditions regarding temperature.
Different types of medical gases must be kept separated from each other. Full and empty cylinders must be stored separately.
Storage of full cylinders in a gas cylinder storage area
Full cylinders must be stored in an UPRIGHT POSITION in a clean, well-ventilated area, free from combustible materials and protected from weather conditions. This room must be designated exclusively for the storage of medical gases and must be locked.
Full and empty cylinders must be stored separately.
Full cylinders must be protected from impacts and falls, and kept away from sources of heat and ignition, as well as from flammable substances. They must also be protected from adverse weather conditions, and in particular from cold. Once delivered by the manufacturer, cylinders must have an intact safety seal.
Transport of full cylinders
Within healthcare facilities, full cylinders must be securely fastened in an UPRIGHT POSITION using appropriate means (trolleys with chains, rings or bars) during transport to protect them from impacts and falls. During transport in vehicles, full cylinders must be securely fastened in an UPRIGHT POSITION. Emergency services must be informed that cylinders must be protected from cold both during transport in vehicles and during outdoor use. For cylinders equipped with residual pressure valves, special care must be taken when connecting the pressure regulator to avoid accidental damage.
Storage of empty cylinders
Empty cylinders must be securely stored in an UPRIGHT POSITION.
Valves must be closed.
6. Contents of the package and other information
Composition of Serynox
- The active substances are:
nitrous oxide 50% and oxygen 50%
- Serynox does not contain any other component.
Appearance of the medicinal product and contents of the pack
Serynox is a colourless compressed medicinal gas.
Aluminium and/or steel gas cylinders of 2 litres, 5 litres, 10 litres, 15 litres and 20 litres (identified with blue and white shoulder and white body), filled to a pressure of 170 bar, equipped with a residual pressure valve and/or valves incorporating an integrated pressure regulator, both featuring a specific outlet connection.
Water capacity of the container [l] | Amount of nitrous oxide/oxygen gaseous mixture equivalent in m³ at 1 bar and 15 °C |
2 | 0.59 |
5 | 1.49 |
10 | 2.97 |
15 | 4.46 |
20 | 5.95 |
Only certain pack sizes may be marketed.
Marketing Authorization Holder and Manufacturing Responsible Party
Marketing Authorization Holder
Messer Ibérica de Gases S.A.U.
Autovía Tarragona-Salou, km. 3.8
E-43480, Vilaseca (Tarragona)
Spain
Manufacturing Responsible Party:
MESSER FRANCE
ZI Lafayette, 35 rue de l'Europe
38790 Saint-Georges-d'Espéranche
France
This medicinal product is authorized in the European Economic Area member states under the following names:
Austria, Germany: Serynox 50% / 50% Gas zur medizinischen Anwendung, druckverdichtet
Belgium: Placynox 50% / 50% v/v medicinaal gas, samengeperst / gaz médicinal comprimé
Croatia: Serynox 50%/50% V/V medicinski plin, stlacen
Czech Republic: Serynox
Estonia, Latvia, Lithuania: Serynox
France: Placynox 50% / 50% gaz médicinal comprimé
Poland: Serynox
Romania: Serynox 50% / 50% Gaz medicinal comprimat
Slovenia: Serynox 50 %/50 % V/V medicinski plin, stisnjeni
Slovakia: Serynox 50% / 50% stlacený medicinálny plyn
Spain: Serynox 50% / 50% gas comprimido medicinal
Date of latest review of this leaflet: November 2020
Detailed and up-to-date information on this medicinal product is available on the website of the Spanish Agency of Medicines and Health Products (AEMPS): http://www.aemps.gob.es/
This information is intended for healthcare professionals only
Serynox cylinders must be used solely for medical purposes.
Prepare full cylinders 48 hours before use
The mixture is unstable below –5 °C; if cooled below this temperature, partial liquefaction of nitrous oxide may occur, resulting in an uneven gas mixture being administered, containing too much oxygen (a mixture with reduced analgesic activity) at the beginning of treatment and too much nitrous oxide (a hypoxic mixture) at the end of treatment. For this reason, full gas cylinders must be stored horizontally for at least 48 hours at a temperature above +10 °C, in a transition area of the pharmacy or maintenance department, prior to first use. Cylinders must be stored in a location protected from impacts, heat sources, ignition sources, and flammable materials. The valves on gas cylinders must be closed.
Place gas cylinders in an UPRIGHT POSITION before first use.
Rooms where Serynox is frequently used must be equipped with an adequate residual gas extraction system or satisfactory ventilation.
Different types of medicinal gases must be stored separately. Full and empty gas cylinders must be stored separately.
Never use oil or grease, even if the cylinder valve is stiff or difficult to connect to the regulator. Handle cylinder valves and associated equipment with clean, grease-free hands (hand cream, etc.).
Turn off the equipment in case of fire or when not in use. If there is a fire risk, move the cylinder to a safe location.
Use only conventional equipment specifically designed for the 50% N2O / 50% O2 gas mixture.
Check that gas cylinders are sealed before first use.
Smoking and open flames are strictly prohibited in rooms where Serynox treatment is administered.
When in use, the cylinder must be secured in an appropriate holder.
After use, the cylinder valve must be firmly closed by hand. Release the pressure from the regulator or connection.
Empty gas cylinders must not be discarded. The supplier will collect empty cylinders.