Document: Niontix medicinal gas, liquefied ENG PL change

• Niontix medicinal gas, liquefied PL
• Niontix medicinal gas, liquefied ENG PL

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Package leaflet: Information for the user

Niontix 100%, medicinal gas, liquefied

Nitrous oxide (medicinal laughing gas)

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 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 or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet:

1. What Niontix is and what it is used for

2. What you need to know before you use Niontix

3. How to use Niontix

4. Possible side effects

5. How to store Niontix

6. Contents of the pack and other information.

1. What Niontix is and what it is used for.

Niontix is a gas (nitrous oxide – laughing gas) which is used by inhalation. It has a slightly sweet taste and smell and is colourless. It comes in a gas cylinder that has a valve to control gas outflow. The gas cylinder contains pure Niontix under such high pressure that the gas is liquefied.

The effects of Niontix

Niontix produces anaesthetic effects – (sleeping effects) – and when you inhale it, you will become relaxed and tired, which may make you fall asleep.

Niontix has painkilling effects, reduces the sensation of pain, and raises the pain threshold. Niontix 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.

What is Niontix used for?

Niontix is used as part of a surgical anaesthetic, or as when painkilling/calming 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.

2. What you need to know before you use Niontix

Niontix is only given to you in a hospital or clinic under the supervision of a healthcare professional. Ensure that your healthcare professional is aware of any medical conditions that you may have.

Do not use Niontix:

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

If as a result of illness or for any other reason it may be suspected that there is air in your pleural cavities outside the lungs, or gas bubbles in your blood or any other organ, e.g. if you have dived with diving equipment and may have gas bubbles in your blood, or if you have recently been treated for eye disorders by injection of gas into the eye, e.g. for a retinal detachment or similar. These gas bubbles may expand during administration of Niontix and thereby cause harm.

If you have heart disease, such as heart failure, Niontix may cause a slight reduction in heart function that may lead to worsening of your condition.

If you have increased pressure in the brain, e.g. resulting from a brain tumour or bleed in the brain, since Niontix can further increase the pressure in the brain with potential risk of harm

If you have severe abdominal discomfort (symptoms that may indicate blockage in the intestines), then Niontix may further increase the dilatation of the gut.

Warnings and precautions

Also inform your doctor or nurse if you have the following signs/symptoms.

If you are suspected of having vitamin B₁₂deficiency or folic acid deficiency, since use of Niontix can worsen the symptoms caused by effects vitamin B₁₂and folic acid deficiency.

Such as ear inflammation, since Niontix may increase the pressure in the middle ear.

Your doctor will decide whether Niontix is a suitable treatment for you.

Other medicines and Niontix

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

• Methotrexate for treating arthritis. Taking Niontix with methotrexate may have an effect on your blood cell count

• If you are taking other medicines which affects the brain or brain function, e.g. benzodiazepines (tranquillising) or morphine like medicines, you should inform your doctor of this. Niontix can increase the effects of these medicines. Niontix in combination with other sedatives, or other medicines affecting the central nervous system, increases the effects of these medicines.

Pregnancy and breast-feeding

If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or nurse for advice before taking any this medicine.

It is recommended to avoid using Niontix during the first six months of pregnancy (because of the potential risk for the foetus). Niontix can be applied during the last three months of pregnancy and during childbirth, but when used close to delivery your baby should be observed for any adverse effects.

You should therefore tell your doctor if you are pregnant.

Laughing gas may be used during breast-feeding, but should not be given during breast-feeding itself.

Driving and using machines

If you have been given Niontix with Medicinal Oxygen, without any other drug, for safety reasons, you should avoid driving, using machines or carrying out complicated tasks until you are fully recovered. (at least 30 minutes)

Always ensure that your healthcare professional advises you whether it is safe for you to drive.

3. How to use Niontix

Niontix is always administered in the presence of medical staff, who will determine the dose you receive. You should always follow the directions of medical staff when you inhale the gas.

Niontix is always given in a gas mixture that contains at least 21% oxygen to avoid the risk of oxygen deficiency (hypoxia). Niontix is normally used in doses (concentrations) that vary between 35 and 75 volume percent of the inhaled gas.

You normally inhale Niontix through a face mask or nasal mask. You either inhale it yourself (“spontaneous respiration”) or you are helped to breathe by a respirator/ventilator, as in anaesthesia.

If you use more Niontix than you should

You should always follow the directions of medical staff when you inhale Niontix. If you find that you have taken too much Niontix and are affected by shortness of breath (too little oxygen in your blood), tell the personnel and stop using Niontix. Depending on the circumstances you may have to breathe ordinary fresh air, or extra oxygen may be administered. The oxygen content of your blood will be continually monitored with the aid of a “pulsoximeter”.

Safety precautions

• Smoking and naked flames are absolutely forbidden in rooms in which laughing gas treatment is being given.

• Niontix (medicinal laughing gas) is intended for medicinal use only.

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

4. Possible side effects

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

Common:may affect up to one in 10 people

Dizziness, light headedness, nausea and vomiting.

Uncommon:may affect up to 1 in 100 people

Feeling of pressure in the middle ear. This is because Niontix increases the pressure in the middle ear.

Abdominal bloating, because Niontix slowly increases the volume of gas in the intestines.

Very rare: may affect up to 1 in 10,000 people)/Not known:cannot be estimated from the available data

Effects on bone marrow and nervous functions.

This is because Niontix affects the quantity of vitamin B₁₂in the body. However, these are extremely rare side effects and the shorter the period of use the less risk there is of them. If Niontix is administered to you over a long period of time, or if you are given Niontix repeatedly at intervals of less than four days, your doctor will probably take blood samples to monitor your blood profile.

Psychiatric effects, such as psychosis.

Reportingof side effects

If you getany side effects, talk to your doctor or nurse.This includes any possible side effectsnot 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 Niontix

This medicinal product does not require any special storage conditions other than those applying to gas containers and gas under pressure (see below).

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

Keep the cylinder in a locked storage reserved for medicinal gases.

Use only in well-ventilated areas.

Must not be exposed to strong heat. Keep away from combustible material.

If at risk of fire – move to a safe place. No smoking.

Handle with care. Make sure the cylinder is not knocked or dropped. Keep the cylinder clean, dry and free of oil and grease.

Store and transport upright with valves closed and, where these are present, with the protective cap and cover in place.

Do not use this medicine after the expiry date which is stated on the cylinder.

6. Contents of the pack and other information

What Niontix contains

• The active substance is nitrous oxide (laughing gas) 100% (chemical symbol N₂O).

• Niontix contains no other ingredients.

What Niontix looks like and contents of the pack

The shoulder of the gas cylinder is marked in blue (nitrous oxide). The body of the gas cylinder is white (medicinal gas). In Finland, the body of the gas cylinder can also be turquoise.

Pack sizes in litres

2.5

4

5

10

20

40

50

450

12x27

9x50

12x40

12x50

Not all pack sizes may be marketed.

Marketing Authorisation Holder:

AGA AB

SE-181 81 Lidingö

Sweden.

Manufacturers

AGA Gas AB ISAGA ehf

Rotevägen 2 Breiðhöfða 11

SE-192 78 Sollentuna IS-110 Reykjavík

Sweden Iceland

Information provided by

Linde Healthcare (a division of AGA AB)

Tel.: 08-731 1000.

“To be completed nationally“

This medicinal product is authorised in the Member States of the EEA under the following names:

Denmark:NIONTIX, 100%,medicinsk gas, flydende

Estonia: NIONTIX, 100%, meditsiiniline gaas, veeldatud

Finland: NIONTIX, 100%, lääkkeellinen kaasu, nesteytetty

Iceland: NIONTIX, 100%, lyfjagas, fljótandi

Latvia: NIONTIX, 100%, medicīniska gāze, sašķidrināta

Lithuania: NIONTIX, 100%, medicininės dujos, suskystintos

Norway: NIONTIX, 100%, medisinsk gass, flytende

Sweden: NIONTIX, 100%, medicinsk gas, flytande

This leaflet was last revised in 2014-08-22

To be completed nationally

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The following information is intended only for health care personnel:

Safety directions

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

• Niontix should be used only in spaces that are well ventilated and/or where special equipment is available which deals with excess gas/exhaled laughing gas. This is in order to avoid excessive concentrations of laughing gas in ambient air, which might affect personnel or other people nearby. There are national guidelines for the concentration of laughing gas that should not be exceeded (“hygienic limit values”).

• The gas cylinder of Niontix should always be kept upright, with the valve upwards. Although Niontix is a gas when it leaves the cylinder, it takes liquid form inside the cylinder because of pressure. If the cylinder is used lying on its side, liquid may leak out and cause injuries such as frostbite.

• The valve should be opened slowly and carefully to avoid releasing liquefied laughing gas.

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

• During use, the cylinder should be fixed in a suitable supporting device.

• The cylinder valve should be closed when a small quantity of gas remains in the cylinder. It is important to leave a small amount of pressure in the cylinder to avoid the entrance of contaminants.

• After use, the cylinder valve should be closed by ordinary hand pressure. Depressurise the regulator or connector.