Kalinox

Leaflet attached to the packaging: information for the patient and user

KALINOX, 50% + 50%, compressed medical gas

Dinitrogenii oxidum + Oxygenium

You should carefully read the contents of the leaflet before using the medicine, as it contains important information for the patient.

• You should keep this leaflet, so that you can read it again if you need to.
• In case of any doubts, you should consult a doctor, pharmacist, or nurse.
• This medicine has been prescribed specifically for you. Do not pass it on to others. The medicine may harm another person, even if their symptoms are the same.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, they should tell their doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What KALINOX, 50% + 50%, compressed medical gas is and what it is used for
• 2. Important information before using KALINOX, 50% + 50%, compressed medical gas
• 3. How to use KALINOX, 50% + 50%, compressed medical gas
• 4. Possible side effects
• 5. How to store KALINOX, 50% + 50%, compressed medical gas
• 6. Contents of the packaging and other information
• 1. What KALINOX, 50% + 50%, compressed medical gas is and what it is used for

KALINOX is a mixture of two medical gases (nitrous oxide 50% and oxygen 50%). It belongs to the category of general anesthetics.
In this concentration, KALINOX does not produce a general anesthetic effect.
The medicine works by reducing sensitivity to pain and allowing the patient to be more relaxed during
certain medical procedures:

• Short, painful procedures in adults and children over 1 month, in particular lumbar punctures ( collecting a sample of fluid from the spine), bone marrow biopsies ( collecting bone marrow samples), minor superficial surgical procedures, dressing burns, setting simple fractures or some joint dislocations ( procedure for setting bones or joints in the correct position), and venipuncture ( blood collection), medical care in emergency situations involving injuries, burns, and transport.
• Dental procedures in infants, young children, children, and adolescents, as well as patients who are anxious about the procedure or have disabilities.
• Childbirth, only in hospital conditions, while waiting for epidural anesthesia, and if the patient refuses such anesthesia or if it is not possible to administer it.
• 2. Important information before using KALINOX, 50% + 50%, compressed medical gas

When not to use KALINOX:

• If the patient has been given an ophthalmic gas (SF6, C2F6, C3F8) used in eye surgery, they should always inform their doctor, so that the doctor can decide whether the administration of the medicine may expose the patient to serious post-operative complications that may be caused by increased pressure inside the eye.
• If the patient's condition requires the administration of 100% oxygen.
• In the case of increased intracranial pressure (high pressure inside the head).
• In the case of impaired consciousness (not entirely normal state of consciousness).
• If the patient is in one of the following situations or has any of the following conditions, associated with the accumulation of air in the body:

Head injury
Maxillofacial injuries
Pneumothorax ( air accumulation between the lung and the chest wall)
Chronic obstructive pulmonary disease ( lung disease causing breathing problems)
Air embolism ( air bubbles in the blood, which can occur, for example, after a diving accident)
After diving
Decompression sickness
After encephalography
During ear and sinus surgery
Air in the abdominal cavity
Diagnosed and untreated vitamin B12 or folate deficiency
During epidural anesthesia
Recently occurring, unexplained neurological disorders

Warnings and precautions

Before starting to use KALINOX, you should discuss it with your doctor or pharmacist.

• The gas should be administered by qualified personnel. However, self-administration of the medicine by the patient is recommended in order to assess the level of consciousness. The patient should NEVERself-administer the KALINOX medicine.
• Rooms where KALINOX is frequently used must be equipped with efficient air conditioning or ventilation systems to maintain the lowest concentration of nitrous oxide in the surrounding air.
• During inhalation, the patient should breathe normally.
• Greasy substances (creams, ointments, etc.) should not be applied to the face before administering KALINOX.
• The effectiveness is lower in children under 3 years of age.
• Newborns should be monitored for adverse reactions, mainly respiratory depression.
• Prolonged and/or repeated administration of the medicine may lead to abuse or dependence.
• In the case of repeated or prolonged administration of the medicine, the doctor may prescribe vitamin B12 to the patient, as it is inactivated by the action of KALINOX.
• If the patient has anemia, atrophic gastritis, intracranial disorders, is on a vegetarian diet, or has alcoholism, they must inform their doctor, as these situations may cause vitamin B12 deficiency.
• If the patient has acute otitis, they should tell their doctor.

KALINOX and other medicines

• If the patient has been given an ophthalmic gas (SF6, C2F6, C3F8) used in eye surgery, they should always inform their doctor, so that the doctor can decide whether the administration of the medicine may expose the patient to serious post-operative complications that may be caused by increased pressure inside the eye.
• Combination with medicines acting on the central nervous system (such as morphine derivatives, benzodiazepines, and other psychotropic medicines) increases sedative action. In the case of concurrent administration of such medicines, the patient's condition should be closely monitored.
• Combination with medicines that affect the action of vitamin B12 and/or folate metabolism may exacerbate the inactivation of vitamin B12. In the case of concurrent administration of such medicines, the patient's condition should be closely monitored.

The patient should tell their doctor or pharmacist about all medicines they are currently taking or have recently taken, as well as any medicines they plan to take.

KALINOX with food, drink, or alcohol

Not applicable

Pregnancy and breastfeeding

KALINOX may be used during pregnancy if the clinical condition requires it.
After short-term administration of nitrous oxide, it is not necessary to interrupt breastfeeding.
Before using any medicine, the patient should consult their doctor or pharmacist.

Driving and using machines

If the patient needs to drive a vehicle or operate machinery after being administered KALINOX (especially in the case of prolonged administration), the patient will be under observation until all adverse reactions have subsided and the patient has regained the same level of alertness as before treatment.

3. How to use KALINOX 50% + 50% compressed medical gas

Dosage

Only medical personnel are authorized to administer KALINOX. Medical personnel will explain the inhalation procedure to the patient and will monitor them throughout the procedure.
The presence of a family member or close person is also possible.
Administration of KALINOX will be stopped immediately in case of loss of verbal contact.
Maximum effectiveness is achieved after at least 3 minutes of inhalation.
This effectiveness is lower in children under 3 years of age.

Method and route of administration

The medicine must be administered in a clean, well-ventilated room.
KALINOX is a mixture of two medical gases inhaled by the patient through a mask
placed on the face and appropriate device.
During inhalation, the patient must breathe normally.
After the procedure, the mask is removed, and the patient must restuntil the action of the medicine has completely subsided.

Duration of treatment

The duration of inhalation of the mixture depends on the duration of the procedure and should not exceed 60 minutes of continuous inhalation per day. If administration is repeated, treatment should not last longer than 15 days.

Overdose of KALINOX:

The patient's skin may turn blue (cyanosis); in such a case, the medical personnel will immediately stop administering the medicine. If cyanosis does not subside within a very short time, the patient will be ventilated using a manual resuscitator - a breathing bag filled with surrounding air or oxygen.

Withdrawal of KALINOX:

Return to a normal state after the end of inhalation is practically immediate, without any residual post-anesthetic effects.
In case of any further doubts related to the use of the medicine, the patient should consult their doctor or pharmacist.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.
The following side effects may occur when using KALINOX. Most of them usually subside within a few minutes after the end of inhalation of the mixture:
Frequent (≥1/100 to1/10):

• Nausea,
• Vomiting.

Uncommon (≥1/1000 to1/100):

• Paresthesia ( tingling),
• Deep sedation ( drowsiness),
• Hallucinations
• Exhaustion,
• Agitation,
• Euphoria,
• Dreams.

Frequency not known (frequency cannot be estimated from the available data):

• Dizziness,
• Headache,
• Seizures,
• Increased intracranial pressure (in patients at risk of increased intracranial pressure - see section: "When not to use KALINOX "),
• Ear pain,
• Disorientation,
• Respiratory depression (in young children),
• Respiratory depression (in newborns, when KALINOX was administered during the perinatal period - see section: "Warnings and precautions "),
• Severe visual disturbances have been observed in patients who received an intraocular injection of gas during eye surgery (see section: "When not to use KALINOX").

After prolonged or repeated exposure:
Frequency not known (frequency cannot be estimated from the available data):

• Abnormal movements, most often due to hyperventilation ( breathing too quickly during ventilation).
• Neurological disorders, such as myeloneuropathies ( spinal cord diseases). These side effects are caused by the inactivation of vitamin B12.
• Megaloblastic anemia with leukopenia ( decrease in red blood cells, with a simultaneous decrease in white blood cells). These side effects are caused by the inactivation of vitamin B12.
• Cases of abuse and dependence
• Vitamin B12 deficiency (see sections "When not to use KALINOX", "Warnings and precautions ","KALINOX and other medicines".

Reporting side effects
If any side effects occur, including any side effects not listed in the leaflet, the patient should tell their doctor, pharmacist, or nurse.
Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products, Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products,
Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: + 48 22 49 21 301, fax: + 48 22 49 21 309,
website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
By reporting side effects, it is possible to gather more information on the safety of the medicine.

5. How to store KALINOX 50% + 50% compressed medical gas

Do not store below 0°C. Do not freeze.
The medicine should be stored in a place that is out of sight and reach of children.
Do not use this medicine after the expiry date stated on the label after EXP. The expiry date refers to the last day of the specified month.
Protect from shocks, falls, heat sources or ignition, flammable materials, and adverse weather conditions, in particular low temperatures.
Full cylinders must be stored IN A HORIZONTAL POSITIONat a temperature between 10°C and 30°C for at least 48 hours before use, with closed valves.

6. Contents of the packaging and other information

What KALINOX 50% + 50% compressed medical gas contains

The active substances of the medicine are:

Nitrous oxide
50% (mol/mol)
Oxygen
50% (mol/mol)

Other ingredients are:

Not applicable

What KALINOX 50% + 50% compressed medical gas looks like and what the packaging contains

Cylinders with a capacity of 2 L, 5 L, 11 L, 15 L, and 20 L.
A 2-liter cylinder filled under pressure of 170 bar provides 0.59 m of gas under pressure of 1 bar
at a temperature of 15°C, which corresponds to 943 g.
A 5-liter cylinder filled under pressure of 170 bar provides 1.47 m of gas under pressure of 1 bar
at a temperature of 15°C, which corresponds to 2358 g.
A 11-liter cylinder filled under pressure of 170 bar provides 3.23 m of gas under pressure of 1 bar
at a temperature of 15°C, which corresponds to 5187 g.
A 15-liter cylinder filled under pressure of 170 bar provides 4.4 m of gas under pressure of 1 bar
at a temperature of 15°C, which corresponds to 7073 g.
A 20-liter cylinder filled under pressure of 170 bar provides 5.9 m of gas under pressure of 1 bar
at a temperature of 15°C, which corresponds to 9431 g.
The cylinders are made of steel or aluminum with a closing valve with an integrated pressure regulator.
Standard color: white body with blue stripes and a white handle.

Marketing authorization holder and manufacturer

Marketing authorization holder AIR LIQUIDESantéINTERNATIONAL

75, quai d’Orsay
75007 Paris - France

Manufacturer: AIR LIQUIDESantéFRANCE

Les petits Carreaux
2, avenue du Lys
94380 Bonneuil-sur-Marne - France

AIR LIQUIDE MEDICAL NV

Tolhuisstraat 46
2627 Schelle - Belgium

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

AUSTRIA:
KALINOX
FRANCE:
KALINOX
ITALY:
KALINOX
POLAND:
KALINOX
PORTUGAL:
KALINOX

Date of last revision of the leaflet:

• 27.08.2024 -----------------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only:

Cylinders containing an equimolar mixture of nitrous oxide and oxygen are intended for medical use only.

FiO2 (oxygen content in the breathing mixture) must not be less than 21%.

Rooms where KALINOX is frequently used must be equipped with a functioning system for removing exhaled gases or a ventilation system.

WHAT TO KNOW BEFORE USING KALINOX

• Personnel using cylinders must be trained in the use of gases.
• Do not use any cylinders that may have been exposed to negative temperatures.
• If frost forms on the cylinder, do not use the cylinder and return it to the pharmacy.
• Do not use a cylinder with an unprotected valve.
• Do not use leaking cylinders.
• Do not lift cylinders by the valve.
• Do not attempt to repair a damaged valve.
• Secure cylinders properly (chains, hooks) to maintain them IN A VERTICAL POSITION WITH THE VALVE UPWARDSand to protect them from accidental falls.
• Never use force to secure the cylinder in the correct position.

WARNINGS FOR THE PERSON ADMINISTERING THE GAS AND THE PATIENT

• Do not stand in front of the gas outlet from the cylinder - always stand on the opposite side of the pressure regulator, at a safe distance from the cylinder. Do not expose the patient directly to the gas stream.
• When connecting the cylinder, have clean, non-greasy hands (without gloves and without using combinations)
• Do not use aerosols (hair spray, deodorant...), organic solvents (alcohol, gasoline...), on the material or near it.
• Do not grease the patient's face with greasy substances (vaseline, ointments, etc.).

CAUTION:

• Do not grease.
• Do not smoke.
• Do not place near fire. In particular: a) Never introduce gas into a device that may contain flammable materials, in particular greasy substances. b) Never clean equipment containing this gas, as well as connecting elements, closures, valves with flammable materials, in particular greasy substances.
• In case of a leak, close the leaky valve. Ventilate well and evacuate the room.
• In case of fire, the risk of poisoning increases due to the production of fumes containing nitrogen compounds

INSTRUCTIONS FOR USE AND HANDLING OF CYLINDERS:

To prevent accidents, the following rules must be observed:
Connection:

Cylinders equipped with a valve

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