Kalinox 50%/50% medicinal compressed gas in cylinders

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

KALINOX 50%/50%, medicinal compressed gas in cartridges

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, ask your doctor, pharmacist, or nurse.
• This medicine has been prescribed for you only, and you should not give it to others, even if they have the same symptoms as you, because it may harm them.
• 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

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

1. What KALINOX is and what it is used for

KALINOX is a mixture of two medicinal gases (50% nitrous oxide and 50% oxygen). It belongs to the group of analgesics (medications that relieve pain).

At this concentration, KALINOX has no anaesthetic effects.

KALINOX is indicated for short-duration painful procedures.

2. What you need to know before starting to use KALINOX

Do not use KALINOX in the following cases

• Any alteration in the level of consciousness that prevents patient cooperation.
• Patients requiring ventilation with pure oxygen
• Head injuries
• Pneumothorax (accumulation of air or gas in the pleural cavity)
• Emphysematous bulla (destruction of lung tissue due to presence of air)
• Gas embolism (obstruction of a blood vessel by air or gas bubbles)
• Decompression sickness
• After recent underwater diving
• After pneumoencephalography
• Abdominal distension due to gas
• Maxillofacial trauma affecting the area where the mask is applied
• During surgery on the middle ear, inner ear, or nasal sinuses
• If air has been injected into the epidural space to determine needle placement for epidural anesthesia
• Patients who have recently received an intraocular gas injection (such as SF6, C3F8, CsF6), as long as an intraocular gas bubble persists or within 3 months following the last intraocular gas injection. Expansion of an intraocular gas bubble by nitrous oxide may cause severe visual impairment.

The use of KALINOX must be immediately discontinued in case of loss of verbal contact.

Warnings and precautions

• The gas must be administered by trained personnel. You must never transport KALINOX cartridges.
• Rooms where KALINOX is used must be equipped with an air conditioning system or adequate ventilation to maintain ambient nitrous oxide levels as low as possible.
• Breathe normally during gas inhalation.
• Do not apply greasy substances (creams, ointments, etc.) to the face prior to administration of KALINOX.
• Treatment success rates are lower in children under 3 years of age.
• Nitrous oxide causes inactivation of vitamin B12 (a cofactor of methionine synthase), which interferes with folate metabolism. Assessment of vitamin B12 levels should be considered in patients with risk factors for vitamin B12 deficiency before using nitrous oxide anesthesia. Risk factors may include patients with anemia or atrophic gastritis, those on a vegetarian diet, or those taking medications that may interfere with vitamin B12 and/or folate metabolism. Vitamin B12 supplementation should be given in cases of repeated or prolonged administration.
• In case of Eustachian tube obstruction, increased pressure in the tympanic cavity may cause ear pain and/or tympanic membrane rupture.
• Abuse, misuse, and diversion: due to the euphoric effects of nitrous oxide, it may be sought and subject to abuse for recreational use.
• Intracranial pressure must be closely monitored in patients diagnosed with and/or at risk of intracranial hypertension, as an increase in intracranial pressure has been observed during nitrous oxide administration in some patients with intracranial disorders.

Use of KALINOX with other medicines

Inform your doctor if you are using or have recently used any other medicines, including those obtained without a prescription.

• If you have been treated with ophthalmic gases (SF6, C2F6, C3F8) during eye surgery, always inform your doctor so that they can ensure administration does not expose you to postoperative complications that could increase intraocular pressure.
• When used in combination with medications acting on the central nervous system (such as morphine derivatives, benzodiazepines, and other psychotropic drugs), the risk of drowsiness, desaturation (reduction in blood oxygen levels), vomiting, and hypotension increases. When combined with these types of medications, patient monitoring must be intensified.
• Medications that interfere with vitamin B12 and/or folate metabolism may potentiate the inactivation of vitamin B12 by nitrous oxide.

Pregnancy and breastfeeding

Consult your doctor or pharmacist before using any medicine.

• The use of KALINOX is not recommended during the first trimester of pregnancy. Nitrous oxide may be used during pregnancy if clinically necessary. When nitrous oxide is used close to delivery, newborns should be monitored for possible adverse effects.
• An increased incidence of spontaneous abortions and congenital malformations has been reported in women exposed to chronic occupational inhalation of nitrous oxide during pregnancy, in the absence of an adequate scavenging or ventilation system.

Driving and use of machines

After administration of KALINOX, driving or operating machinery is not recommended until all side effects have subsided and normal consciousness has been restored.

3. How to use KALINOX

Follow exactly the administration instructions for this medicine as given by your doctor. Consult your doctor if you have any doubts.

Administration must be carried out in suitable premises by specialist doctors or qualified nurses specifically trained and responsible for continuous patient monitoring.

The duration of the inhalation of the mixture depends on the length of the corresponding procedure and must not exceed 60 consecutive minutes. In case of daily administration, it must not exceed 15 consecutive days. After discontinuation of inhalation, return to the initial condition is almost immediate and without residual effects.

The flow rate of the mixture (amount of gas received per second or per minute) is determined by the patient's spontaneous ventilation.

Use in painful procedures:

Before starting the procedure, the mask should be kept in place for 3 minutes. During this time, verbal contact with the patient should be maintained. The person supervising the administration confirms when it is appropriate to begin the procedure. Gas inhalation is maintained throughout the procedure, instructing the patient to breathe normally.

During administration, monitoring is essentially clinical. The patient should remain relaxed, breathe normally, and respond to simple commands. If deep sedation occurs, with loss of verbal contact, the mask must be removed until verbal contact is re-established.

Use in dentistry:

In patients whose disability prevents them from properly maintaining the mask in position, another person should hold it in place without applying excessive pressure. After 3 minutes, the procedure may proceed uninterrupted if a nasal mask is used, or in periods of 20 to 30 seconds if a buccal-nasal mask (covering nose and mouth) is used, which in these cases should be lifted off the nose during the mentioned intervals.

At the end of the procedure, the mask should be removed and the patient should remain resting in the dental chair for 5 minutes.

Use in obstetrics (pregnancy, childbirth, and postpartum):

Gas inhalation should begin at the onset of contractions, before pain appears. The laboring woman should breathe normally during contractions and avoid hyperventilation (rapid or deep breathing causing a sensation of breathlessness), due to the risk of oxygen desaturation (reduction in blood oxygen levels) between contractions. Inhalation of the gas should be stopped once pain subsides. Continuous monitoring of oxygen levels is recommended for this indication.

If you use more KALINOX than you should

If you have used more KALINOX than recommended, consult your doctor immediately or call the Toxicology Information Service at telephone number 91-562 0420, indicating the medicine and the amount taken.

If stored improperly at temperatures below 0°C, cyanosis (lack of oxygen) may occur. In this case, both gases (nitrous oxide and oxygen) may exit the container separately.

If cyanosis occurs during administration, treatment must be immediately suspended; if, despite this, cyanosis does not rapidly resolve, the patient must be ventilated using a manual bag filled with ambient air.

Overdose may cause increased dizziness, unconsciousness, cyanosis, and death due to anoxia.

Under these circumstances, treatment must be stopped immediately and appropriate measures must be taken.

4. Possible adverse effects

Like all medicines, KALINOX can cause adverse effects, although not everyone will experience them.

Nitrous oxide diffuses into gas-containing spaces faster than nitrogen. The use of nitrous oxide may result in the expansion of non-ventilated gas-containing cavities.

Frequent (> 1/100 to < 1/10):

Gastrointestinal disorders: Nausea, vomiting

Uncommon (> 1/1,000 to < 1/100):

Nervous system disorders: paresthesia, excessive sedation

Psychiatric disorders: euphoria, agitation, anxiety, hallucinations, dreams

Unknown (cannot be estimated from available data):

Nervous system disorders: dizziness, myelopathy, neuropathy, increased intracranial pressure, generalized seizures

Blood and lymphatic system disorders: megaloblastic anemia, pancytopenia (observed under predisposing conditions (cobalamin deficiency, substance abuse)), leukopenia/agranulocytosis (observed after very high and prolonged exposures during treatment for tetanus in the 1950s)

Eye disorders: Severe visual impairment (caused by expansion of intraocular gas)

Ear and labyrinth disorders: Ear pain, disorders of the middle ear, rupture of the tympanic membrane (in case of Eustachian tube obstruction)

Respiratory, thoracic and mediastinal disorders: Respiratory depression (in the newborn, when nitrous oxide is used during childbirth)

Metabolic and nutritional disorders: Vitamin B12 deficiency

Psychiatric disorders: Disorientation

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or pharmacist, even if it is a possible adverse effect not listed in this leaflet. You may also report it directly through 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 KALINOX

Keep out of the sight and reach of children.

The cartridges must be stored HORIZONTALLY, between 10 and 30°C, for at least 48 hours prior to use, with valves closed.

Protect the cartridges from impacts, falls, heat sources or ignition sources, flammable materials, adverse weather conditions, and in particular from cold temperatures.

Do not use KALINOX after the expiry date stated on the packaging after "EXP". The expiry date refers to the last day of the month indicated.

All regulations relating to the handling of pressurized containers must be observed.

6. Contents of the package and other information

Composition of KALINOX

• The active substances are: nitrous oxide and oxygen. Each cartridge contains a mixture of both components at 50% (mol/mol).
• Does not contain any other components (excipients).

Appearance of the product and contents of the pack

KALINOX is packaged in cartridges, available in the following sizes:

Valve type legend:

1 Cylinder available with valve without integrated pressure regulator (Standard RPV valves).

2 Cylinder available with valve with integrated pressure regulator (Compact G2 (Compact) valves).

3 Cylinder available with valve with integrated pressure regulator (M706 (One K) valves).

Only certain cylinder sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder:

AIR LIQUIDE Santé INTERNATIONAL
75, Quai D'Orsay
75007 - Paris (France)

Manufacturer:

AIR LIQUIDE MEDICAL
Tolhuisstraat 46-48
2627 - Schelle (Belgium)

AIR LIQUIDE Santé FRANCE
Les petits carreaux
2, avenue du Lys
94380 Bonneuil sur Marne
France

Date of latest revision of this leaflet: June 2024

Instructions for use and handling

KALINOX is intended for hospital use only.

The oxygen concentration (FiO2) must never be less than 21%.

To prevent accidents, the following instructions must be observed:

• Personnel handling the cylinders must be trained in the use of gases.

• Do not use any cylinder suspected of having been exposed to temperatures below 0°C.

• If frost is observed on the cylinder, do not use it and return it.

• Do not handle a cylinder whose valve is not protected by a cap.

• Never use a cylinder that is leaking.

• Do not lift the cylinder by its valve.

• Do not attempt to repair a defective valve.

• Secure cylinders with appropriate means (chains, tie-down hooks, etc.) to keep them in an UPRIGHT POSITION and prevent them from falling.

• Never force a cylinder into a holder if it does not fit easily.

• Ensure adequate ventilation of the area of use. In case of prolonged use, accident, or unexpected leakage, ensure that gases can be evacuated. The Time-Weighted Average Exposure Limit for nitrous oxide has been set at 50 ppm with respect to personnel exposure.

• Never stand directly in front of the valve outlet; instead, position yourself on the side opposite the flowmeter gauge, behind the cylinder and at a safe distance. Under no circumstances should the patient be exposed to the gas flow.

• Handle equipment with clean, grease-free hands.

• Do not use aerosol generators (hairspray, deodorant, etc.) or solvents (alcohol, gasoline, etc.) on or near the equipment.

• Do not apply greasy substances (vaseline, ointments, etc.) to the patient's face.

• Do not grease.

• Do not smoke.

• Do not bring near flame.

And in particular:

• Never introduce this gas into a device that might contain flammable substances, especially greasy materials.

• Never clean devices containing this gas, valves, seals, closure devices, or circuits with flammable products, especially greasy materials.

In case of leakage, close the valve that is leaking. Ventilate the area thoroughly and evacuate if necessary.

In case of fire, the risk of toxicity increases due to the formation of nitrous vapors.

For cylinders equipped with valves:

• Slightly open the cylinder valves before connecting the pressure regulator to remove any particles or foreign matter. Always keep the contact point between the cylinder and the pressure regulator clean.
• The cylinders are equipped with a pressure-flowmeter gauge: They have a specific connection for medical nitrous oxide – oxygen mixture, in accordance with standard NF S 90-116.
• Use a pressure regulator with a flowmeter capable of measuring pressures of at least 1.5 times the cylinder's maximum working pressure.

To open the cylinder after connection:

• Follow the instructions on the cylinder label.
• Never force the valve when opening it, and never open it fully.
• Always open the valve slowly to prevent cooling, which could cause dehomogenization of the mixture.
• Never repeatedly pressurize the pressure regulator.
• Do not transfer gas from a low-pressure cylinder to another cylinder.

After use:

• Close the cylinder valve after use and allow the pressure gauge reading by leaving the flowmeter open; then close the flowmeter and loosen the pressure regulator adjusting screw.
• Never completely empty a cylinder; always leave a minimum pressure of 10 bar.

Keep empty cylinders in an UPRIGHT POSITION with valves closed (to prevent corrosion due to moisture).