Document: Medicinsk lustgas Yara Praxair medicinal gas, liquefied ENG PL change

• Medicinsk lustgas Yara Praxair medicinal gas, liquefied PL
• Medicinsk lustgas Yara Praxair medicinal gas, liquefied ENG PL

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Package leaflet: Information for the user

Medicinal nitrous oxide Yara Praxair100 %, medicinal gas, liquefied

Nitrous oxide (N₂O)

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.

• If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet.

What is in this leaflet:

1. What Medicinal nitrous oxide Yara Praxair is and what it is used for

2. What you need to know before you use Medicinal nitrous oxide Yara Praxair

3. How to use Medicinal nitrous oxide Yara Praxair

4. Possible side effects

6. Contents of the pack and other information

Medicinal nitrous oxide Yara Praxair is a medicinal gas that is used for pain relief or, in combination with other anaesthetic agents as an anaesthetic during surgery.

Medicinal nitrous oxide Yara Praxair is administered by inhalation. When inhalating this medicinal gas you will start feeling relaxed and sleepy, and may fall asleep. Additionally, nitrous oxide has an analgesic effect. The effects of nitrous oxide are caused by its effect on chemical entities in your body called neurotransmittors, which regulates awakeness and perception of pain.

Do not use Medicinal nitrous oxide Yara Praxair

• may have air in your pleural sack (pneumothorax), e.g. due to a disease or other reasons

• recently have been diving with diving equipment

• may have air or gas filled bubbles in your body (gas embolus)

• recently have been treated in a heart-lung machine

• recently had a severe head injury

The air bubbles may expand during administration of nitrous oxide.

• If you have recently been treated with a gas injection in the eyeball due to an eye disorder. Increased pressure in the eyes may cause blindness.

• If you suffer from severe abdominal discomfort. The symptoms may indicate ileus. Nitrous oxide may increase the intestinal distension.

• If you have a heart disease, e.g. heart failure or severely impaired cardiac function (e.g. after cardiac surgery). Nitrous oxide may cause further impairement of the heart function.

• If you have increased pressure in your brain which causes confusion or altered consciousness. Nitrous oxide may increase the pressure further.

• If your consciousness or capacity to cooperate decrease when you get nitrous oxide. Nitrous oxide may inhibit protective reflexes.

Warnings and precautions

Talk to your doctor or nurse before taking Medicinal nitrous oxide Yara Praxair. Inform your doctor if you suffer from any of the following disorders:

• Low vitamin B₁₂ levels. Nitrous oxide may increase the symptoms caused by lack of vitamin B₁₂.

• If you have an ear disorder. Nitrous oxide may increase the pressure in the middle air.

Other medicines and Medicinal nitrous oxide Yara Praxair

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

Nitrous oxide may increase the effect of other anaesthetic agents.

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 pharmacist for advice before taking this medicine.

Medicinal nitrous oxide Yara Praxair may be used when giving birth, but should be used with caution during the first six months of your pregnancy.

Medicinal nitrous oxide Yara Praxair may be given while you are lactating, but should not be given simultaneosuly as you are feeding your baby.

Inform your doctor or nurse if you are pregnant or breast-feeding.

Driving and using machines

Medicinal nitrous oxide Yara Praxair has a sedative effect. You should not drive, operate tools/machines, or perform other demanding activites shortly after using nitrous oxide but wait until the effect has disappeared totally.

Administration of Medicinal nitrous oxide Yara Praxair should always takes place under the supervision of health care personnel. Always use this medicine exactly as your doctor or nurse has told you.

Use the gas cylinder in an upright position.

Medicinal nitrous oxide Yara Praxair is administered in combination with oxygen as a mixture containing at least 21 % oxygen in order to avoid lack of oxygen (hypoxia). The usual dose (concentration) is 35 to 75 volume % nitrous oxide. When used as an anaestehtic, a mixture of nitrous oxide and oxygen will be administered together with other anasethetic agents.

Medicinal nitrous oxide Yara Praxair will be given via a mask or a breathing piece. You may inhalate the gas by yourself (spontaneous inhalation) or it may be given by means of a respirator or ventilator.

Smoking and open fire are forbidden in rooms where nitrous oxide therapy is being carried out. Medicinal nitrous oxide Yara Praxair must only be used for medicinal purposes.

If you use more Medicinal nitrous oxide Yara Praxair than you should

Inform the health care personnel if you get problem breathing. The amount of nitrous oxide will then be reduced or the supply interrupted.

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

4. Possible side effects

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

Common side effects (affects more than 1 out of 100 patients)

Dizziness, feeling of intoxication, nausea, vomiting

Uncommon side effects (affects more than 1 out of 1000 patients but less than 1 out of 100 patients)

Feeling of pressure in the middle ear, bloating, increased gas volume in the bowel

Very rare side effects (affects less than 1 out of 10 000 patients)

Effects on your bone marrow and nervous system, because exposure to nitrous oxide may affect vitamin B₁₂ levels. These side effects are very rare and the risk decreases with decreased period of exposure. If you receive nitrous oxide for a longer period, or very frequently, your doctor may want to take blood samples to monitor your blood levels of e.g. vitamin B₁₂.

If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet.

5. How to store Medicinal nitrous oxide Yara Praxair

Keep this medicine out of the sight and reach of children. Store below 45 °C.

Store gas cylinders upright in a locked and well-ventilated room reserved for medicinal gases.

Do not expose it to strong heat.

Smoking is not allowed.

Keep the gas cylinder dry and clean, and prevent it from being knocked or dropped.

Gas cylinders should be stored and transported 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 label attached to the gas cylinder. The expiry date refers to the last day of that month.

6. Contents of the pack and other information

What Medicinal nitrous oxideYara Praxair contains

• The active substance is 100 % nitrous oxide.

• Medicinal nitrous oxide Yara Praxair does not contain any other ingredients.

What Medicinal nitrous oxideYara Praxair looks like and contents of the pack

Medicinal nitrous oxide Yara Praxair is a colourless gas without appreciable odour or taste. It is marketed in a steel cylinder as a colourless liquid under pressure.

Cylinder sizes (litres)	2,5	4	10	40	50	12x40	12x50
Content, gas (kg)	1,9	3.0	7.5	30	37.5	360	450
Content, gas (litres)	1009	1 615	4 035	16 140	20 175	193 680	242 100

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder	Manufacturer
Praxair Scandinavia Holding AS P.O. Box 23, Haugenstua N-0915 Oslo Norway	Ijsfabriek Strombeek n.V Broekstraat 70 BE-1860 Meise Belgium

This leaflet was last approved in 2016-08-19

Detailed information on this medicine is available on the web site of [to be completed nationally].

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

If the batch label is missing or is illegible, please do not use the cylinder but return it to Yara Praxair AS.

General

Medicinal gases must be used for medicinal purposes only.

Never use oil or grease even if the cylinder valve should be stiff or the regulator is difficult to connect. Handle valves and associated devices with clean, grease-free (hand cream etc.) hands.

Use only standard equipment that is designed for medicinal laughing gas (nitrous oxide).

Make sure the cylinders are sealed before they are used.

Remaining pressure at return should be > 2 bar (200 kPa).

Preparation prior to use

Remove the seal from the valve before use.

Use only regulators designed for nitrous oxide. Check that the attachment on the connector or regulator is clean and that the attachments are in good condition.

Never use tools to tighten a pressure/flow regulator intended to be tightened by hand, since this may damage the connection.

Open the cylinder valve gently, by at least half a revolution.

Do a leakage check in accordance with the instructions accompanying the regulator. Do not attempt to remedy leakage from the valve or equipment other than by changing the gasket or ‘O’ ring.

If leakage occurs, close the valve and disconnect the regulator. Mark faulty cylinders, put them in the space reserved for rejections and return them to the supplier.

Using the gas cylinder

Smoking and naked flame are absolutely forbidden in rooms in which nitrous oxide treatment is being given.

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

Remove to a safe place if there is a danger of fire.

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.