Document: Kalinox medicinal gas, compressed ENG PL change

• Kalinox medicinal gas, compressed PL
• Kalinox medicinal gas, compressed ENG PL

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Package leaflet: information to the user

Kalinox 50 %/50 % medicinal gas, compressed

Nitrous oxide / Oxygen

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.

• This medicine has been prescribed for you only. Do not pass it on to others. It may harm them, even if their signs of illness are the same as yours.

• 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.

What is inthis leaflet:

1. What Kalinox is and what it is used for

2. What you need to know before you use Kalinox

3. How to use Kalinox

4. Possible side 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 contains a ready mixture of nitrous oxide (medicinal “laughing gas”, N₂O) and oxygen (medicinal oxygen, O₂), 50% of each, and should be used by breathing in the gas mixture.

The effects of Kalinox

The nitrous oxide constitutes 50% of the gas mixture. Nitrous oxide has a painkilling effect, reduces the sensation of pain, and raises the pain threshold. Nitrous oxide also has a relaxing and slightly calming effect. These effects are produced by the effects of nitrous oxide on signal substances in your nervous system.

The 50-percent concentration of oxygen, around double that in ambient air, guarantees a safe oxygen content in the inspired gas.

What Kalinox is used for

Kalinox should be used when painkilling effects, of rapid onset and rapid resolution are desired and when the treated pain state is of mild to moderate intensity and of limited duration. Kalinox produces painkilling effects after just a few breaths and the painkilling effects subside within minutes after use is ceased.

2. What you need to know before you use Kalinox

Do not use Kalinox:

Before you use Kalinox you should inform your doctor if you have any of the following signs/symptoms:

• Hypersensivity of the active substance

• If your condition requires administration of 100% oxygen.

• Pneumothorax (accumulation of air between the lung and the chest wall or injuries in face or jaw),

• Severe emphysema (disease of the lung alveoli resulting in respiratory problems),

• Gas embolism (formation of air bubbles in the bloodstream), Performed deep sea diving with risk of decompression sickness,

• Head injury or injuries in face or jaw,

• Had treatment with heart lung machine or coronary by pass without heart lung machine,

• Have received an injection of ophthalmic gas during eye surgery in the last three months, as there is a risk of blindness if the pressure in the eye gets too high. Your doctor will ensure that the pressure does not harm you.

• Presence of air in the abdomen which causes severe abdominal discomfort,

• Had air encephalography (X-ray of the brain),

• Middle ear, inner ear and sinus surgery,

• Had an epidural anaesthesia and air has been injected

In addition Kalinox must not be usedif you have:

• Facial injury where use of a face mask may present difficulties or risks.

• A decreased level of consciousness or impaired ability to cooperate and follow instructions due to the risk that further sedation from the nitrous oxide may affect natural protective reflexes.

• Untreated vitamin B12 or folic acid deficiency, or diagnosed disorder of the metabolism of these vitamins.

Warnings and precautions

Also inform your doctor if you have any of the following signs/symptoms:

• Ear discomfort: e.g. ear inflammation, since Kalinox may increase the pressure in the middle ear.

• Vitamin deficiency: If you are suspected of having vitamin B₁₂ deficiency or folic acid deficiency, since use of nitrous oxide can worsen the symptoms caused by vitamin B₁₂ and folic acid deficiency.

Your doctor will decide whether Kalinox is suitable for use.

Other medicines and Kalinox

Please tell your doctor or pharmacistif you are taking or have recently taken any other medicines.

Tell your doctor if you:

Pregnancy, breast-feeding and fertility

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, askyour doctor for advice before taking thismedicine.

Kalinox can be applied during pregnancy and during childbirth. When used close to delivery your baby should be observed for any adverse effects.

Kalinox can be used during the breast-feeding period.

Driving and using machines

Kalinox has an intoxicating effect. For reasons of safety you are therefore advised to avoid driving a motor vehicle, using machines, or carrying out complicated tasks until you are fully recovered.

It is your own responsibility to judge whether you are able to drive or to perform activities which require extra attention. One of the factors which can affect your abilities in this respect is the use of drugs, due to their effects and/or side-effects. A description of these effects and side-effects can be found in other sections of this document. You should therefore read all information in this leaflet for guidance. You should check with your doctor or pharmacist if you are not sure.

3. How to use Kalinox

Kalinox is always administered in the presence of personnel who are familiar with this form of medicine. Throughout the period during which you use Kalinox you, and the administration of the medicine should be monitored to ensure that it is administered safely. Even after completion of administration you will be monitored by competent personnel until you have recovered.

You should always use Kalinox in accordance with the doctor’s instructions. Your doctor should explain to you how to use Kalinox, how Kalinox works, and what effects arise from use.

You normally inhale Kalinox through a face mask attached to a special valve, which means that you have full control of the flow of gas by virtue of your own breathing. The valve is only open during inspiration. Kalinox can also be administered via a so-called nasal mask.

Irrespective of which mask you use, you should breathe normally with normal breaths in the mask.

After you stop using Kalinox you should rest and recover until you feel you have recovered mentally.

Safety precautions

• Smoking and open fire is strictly forbidden in rooms where treatment with Kalinox is taking place.

• Kalinox is intended for medicinal use only

If you use more Kalinox than you should

You are very unlikely to receive too much gas, since you govern the supply of gas yourself and the gas mixture is fixed, (contains 50% nitrous oxide and 50 % oxygen).

If you breathe quicker than normal and thereby receive more nitrous oxide than you would with normal breathing, you may feel noticeably tired and may to some extent feel out of touch with your surroundings. In such circumstances you should immediately inform the medical staff and stop the administration.

If you have any further questions on the use of this product, ask your doctor or pharmacist.

4. Possible side effects

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

Contact your doctor or go to nearest hospital immediately if you develop an infection with symptoms such as fever coupled with a severely deteriorated general state of health or a fever with local infection symptoms such as sore throat/mouth or difficulty urinating (agranulocytosis).

The following undesirable effects may occur during treatment and usually disappear within minutes of discontinuationof inhalationofthemixture:

Common(≥1/100 to <1/10):

Nausea and vomiting

Uncommon (≥1/1,000to <1/100)

Paraesthesia(tingling),deepeningofsedation(drowsiness),hallucinations,anxiety,agitation,euphoria, dreams.

Not known: (cannot be estimated from the available data)

dizziness,headache, convulsion, increased intracranial pressure, severe visual impairment, ear pain, middle ear disorders, tympanic rupture, respiratory depression in the neonates during delivery, disorientation, vitamin B12 deficiency.

Neurologicaldisorderssuchasmyeloneuropathies(spinalcord diseases).

Megaloblasticanaemiawithleukopenia (adecreaseinthenumberofredbloodcells,accompaniedbya decrease inthenumberofwhitebloodcells).

Pancytopenia (severe reduction in blood cellswhich can causeweakness, bruising or make infections more likely).

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist or nurse.This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V*. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Kalinox

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

Do not use after the expiry date which is stated on the gas cylinder after EXP.

The expiry date refers to the last day of that month.

Do not store below -5°C

On suspicion that Kalinox has been stored in too cold conditions, the cylinders should be stored in horizontal position at a temperature above +10C for at least 48 hours before use.

Keep the cylinder in locked storage reserved for medicinal gases.

Keep away from combustible material.

Use only in well-ventilated areas.

No smoking. Must not be exposed to strong heat.

If at risk of fire, move to a safe place. Keep the cylinder clean, dry and free from oil and grease.

Make sure the cylinder is not knocked over or dropped.

Store and transport with valves closed.

6. Contents of the pack and other information

What Kalinox contains

• The active substances are:
  nitrous oxide 50% = medicinal laughing gas (chemical term: N₂O) and
  oxygen 50%= medicinal oxygen (chemical term: O₂)

• Kalinox contains no other ingredients

What Kalinox looks like and contents of the pack

Kalinox is a colourless, odourless gas without taste, which is supplied in a gas cylinder with a valve to control the gas flow.

Pharmaceutical dosage form: medicinal gas, compressed

The shoulder of the gas cylinder is marked in white and blue (oxygen/nitrous oxide). The body of the gas cylinder is white (medicinal gas).

Pack sizes in litres	2	2.5	3	5	5	11	15
Volume gas in litres at atmospheric pressure and 15C	590	519	623	1038	1470	2284	4400

Not all pack sizes may be marketed.

Marketing authorisation holder:

<To be completed nationally>

Manufacturer

Air Liquide Medical

Tolhuisstraat 46

B-2627 Schelle

Antwerpen

Belgium

AIR LIQUIDE Danmark A/S

Havnegade 153

DK-5000 Odense C

Denmark

Information supplied by: <To be completed nationally>

This leaflet was last revised in 21 September 2016

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The following information is intended for medical or healthcare professionals only:

Safety directions

Special precautions should be taken when working with nitrous oxide. Nitrous oxide should be administered according to local guidelines.

Kalinox should only be used in areas that are well ventilated and where there is special equipment to evacuate excess gas. By using a scavenging system and ensuring good ventilation, high atmospheric concentrations of laughing gas in ambient air are avoided. High concentrations of laughing gas in ambient air may cause negative health effects in personnel or other people in the vicinity. There are national guidelines for the concentration of laughing gas that should not be exceeded in ambient air, so-called “hygienic limit values”, often expressed as TWA (time weight average), the mean value over a working day and STEL (short-term exposure limit), the mean value during a shorter exposure.

These values should not be exceeded in order to guarantee that personnel are not exposed to risk.

• The valve should be opened slowly and carefully.

• Turn off the equipment in the event of fire, or if not in use.

• During use the cylinder must be fixed in a suitable support.

• One should consider replacing the gas cylinder when the pressure in the bottle has dropped to a point where the indicator on the valve is within the yellow field.

• When a small quantity of gas is left in the gas cylinder, the cylinder valve must be closed. It is important to leave a small amount of pressure in the cylinder to avoid the entrance of contaminants.

• After use the cylinder valve must be closed hand-tight. Depressurise the regulator or connection.

Information about the gas cylinder

Maintenance

• The Kalinox gas cylinder should be regularly maintained by personnel trained by the supplier.

• The life expectancy of the gas cylinder is maximum 10 years.

• If the cylinder is used in extreme environmental conditions (e.g. transportation, storage or use in very humid environments) it is recommended that the correct function of cylinder is checked every six months.

Cleaning and disinfection of the aluminium cylinders with shut-off valve withintegrated pressure and flow regulators

• Only the protective cover and the protective glass covering the manometer 5 should be cleaned by the user.

• The cylinder should be cleaned only with the valve closed (no matter if it is full or empty), and only with a damp cloth. Do not use detergents containing abrasive, alcohol, acetone or other flammable liquids.

NOTE for the aluminium cylinders with shut-off valve withintegrated pressure and flow regulators

• Never try to repair a defective regulator or other mechanisms of the Kalinox gas cylinder.

• In case of suspected leakage, turn the flow valve (grey handle 2) to position “Open” and thereafter close the closing valve (blue handle 1) to position “Close”. Isolate the cylinder and return it as soon as possible to Air Liquide Gas AB.

• In case the cylinder becomes extremely dirty, store it separately and return it as soon as possible to Air Liquide Gas AB.