100%, medical gas, liquid
Nitric oxide (medical nitrous oxide)
What Niontix is and what it is used for
Niontix is a gas (nitrous oxide, nitrous oxide) used for inhalation. It has a faintly sweet taste and smell and is colorless. It is provided in a gas bottle that has a valve to control the outflow of gas. The gas bottle contains pure Niontix under such a high pressure that the gas is liquid.
The effects of Niontix
Niontix provides anesthetic effects – (sleeping effects) and will make you relaxed and tired when inhaled and it can make you fall asleep – asleep. Niontix has an analgesic effect, reduces the pain experience, and raises the pain threshold. Niontix also provides a relaxing and slightly soothing effect. These effects are caused by nitrous oxide affecting neurotransmitters in your nervous system.
What is Niontix used for?
Niontix is used in all age groups as part of the anesthesia during surgery, or when rapid onset and rapidly subsiding analgesic / calming effects are desired and when the intensity one in the pain being treated is mild to moderate and short-lived.
What you need to know before you use Niontix
You will only receive Niontix when you are in hospital or doctor’s surgery and under the supervision of a healthcare professional. Tell your healthcare provider if you have any other illnesses.
Do not use Niontix:
- Inhalation of nitrous oxide (Niontix), can cause gas bubbles in the body and cause gas-filled spaces to expand and thus cause damage. Therefore, do not use Niontix if you:
- have air in the lung or heart sac (eg due to illness or injury), have a severe type of pulmonary emphysema (eg due to smoking), air or gas-filled bubbles in the body.
- have recently dived with diving equipment and thus may be at risk of diving disease.
- has recently been treated in a heart / lung machine.
- has recently suffered a severe head injury.
- If you have recently been treated with an injection of gas into the eyeball, due to an eye disease. Increased pressure in the eye can cause blindness.
- If you have severe stomach problems.
- If you have heart failure or severe heart function (eg after heart surgery). Nitrous oxide can cause a further deterioration of heart function.
- If you have increased pressure in the brain, which can make you confused or affect your level of consciousness. The nitrous oxide can further increase the pressure.
- If your level of awareness or ability to cooperate and follow instructions decreases when you receive nitrous oxide. Nitrous oxide can inhibit protective reflexes.
- If you have a diagnosed but untreated vitamin B 12 deficiency or folic acid deficiency or have a genetic disorder in the enzyme systems involved in the metabolism of these vitamins , as the use of nitrous oxide may further aggravate the deficiency.
- In case of injury to the jaw and face, then the use of a face mask can involve difficulties or risks.
Warnings and cautions
Talk to your doctor or nurse before using Niontix if you have any of the following symptoms/symptoms/conditions.
- Affected cardiac functionBecause the slightly relaxing effect that nitrous oxide has on the heart muscle can further impair heart function.
- Ear problemssuch as ear inflammation, as Niontix may increase the pressure in the middle ear
- Have or have had drug or drug abuse , as there is then a higher risk of developing dependence on nitrous oxide during repeated use. Your doctor will decide if treatment with Niontix is appropriate in your case.
- Vitamin deficiencyIf you suspect you have vitamin B 12 deficiency or folic acid deficiency, then the use of Niontix may aggravate the symptoms caused by vitamin B 12 deficiency and folic acid.
Your doctor will assess whether it is appropriate to use Niontix.
Repeated or prolonged use of nitrous oxide can increase the risk of vitamin B 12 deficiency, which can lead to damage to the bone marrow or the nervous system. Your doctor may perform blood tests before and after treatment, to assess the consequences of any vitamin B 12 deficiency.
Other medicines and Niontix
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
- Methotrexate for the treatment of e.g. rheumatoid arthritis . Using Niontix with methotrexate may affect your blood count.
- If you are taking other medicines that affect the brain or brain functions e.g. benzodiazepines (sedatives) or morphine-like medicines, tell your doctor. Niontix may potentiate the effects of these medicines. Niontix in combination with other medicines that affect the central nervous system increases the risk of side effects from these medicines
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, ask your doctor or nurse for advice before taking this medicine.
Niontix can be used during pregnancy if your doctor thinks it is medically necessary. It can also be used during childbirth. If Niontix is used near the time of delivery, your baby should be monitored for breathing difficulties ( respiratory depression ) and other side effects.
Nitrous oxide can be used during the breastfeeding period, but should not be used during the actual breastfeeding session.
Driving and using machines
If you have only been given Niontix together with medical oxygen, without any other medicines, you should, for safety reasons, avoid driving, using machines, or performing complicated tasks until you are fully recovered (for at least 30 minutes).
Always make sure that your healthcare professional gives you advice when it is safe for you to drive a car.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires sharpened vigilance. One of the factors that can affect your ability in these respects is the use of drugs due to their effects and/or side effects. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
How to use Niontix
Niontix is always given in the presence of healthcare professionals who decide what dose you receive. You should always follow the instructions of your healthcare professional when breathing the gas.
At all times you receive Niontix, healthcare professionals should monitor you to ensure that inhalation is given and used safely. After inhalation, you will be monitored by a healthcare professional until you have recovered.
You usually breathe Niontix through a face mask or nasal mask. Either you breathe yourself – you “spontaneously breathe” or you get help to breathe from a respirator/ventilator, as in anesthesia. It is given as a gas mix with oxygen and the doctor ensures that the oxygen concentration is high enough to avoid oxygen deficiency.
Anesthetic
When anesthetized, Niontix is combined with other anesthetics, and the concentration needed for an anesthetic effect is determined by your doctor.
Pain-relieving and calming effect
When used for an analgesic or sedative effect, rapid onset, and rapid resuscitation, Niontix is inhaled for the duration of the procedure or for as long as the analgesic effect is desired.
Use for children
Your doctor will make sure that an appropriate dose is given and that your child is closely monitored, due to the potential risk of unconsciousness and loss of protective reflexes (eg vomiting reflex) at higher doses.
If you use more Niontix than you should
You should always follow the instructions of your healthcare professional when breathing Niontix. If you feel that you have been given too much Niontix and have an air hunger (get too little oxygen in your blood) or experience a decrease in consciousness, stop inhaling one of Niontix and make the staff aware of this. Depending on the circumstances, you will be able to breathe ordinary fresh air or you will be given extra oxygen. Your oxygen content in the blood will be monitored continuously using a so-called pulse oximeter.
Safety instructions
- Smoking and open fire are strictly prohibited in rooms where nitrous oxide treatment is in progress.
- Niontix (medical nitrous oxide) is for medical use only.
See also instructions on storage and handling of gas cylinders. (5. How to store Niontix).
If you have any further questions on the use of this product, ask your doctor or nurse.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Common can occur in up to 1 in 10 users:
- Dizziness, dizziness, euphoria
- Nausea and vomiting
Uncommon may occur in up to 1 in 100 users:
- Ears are blocked. This is because Niontix increases the pressure in the middle ear.
- Flatulence due to Niontix slowly increasing the volume of gas in the intestines.
No known frequency (can not be calculated from the available data):
- Effects on nerve function, numbness and weakness, usually in the legs
- Respiratory depression (shallow and slow breathing)
- Mental effects such as anxiety and psychosis
- The following symptoms occur because Niontix affects the amount of vitamin B 12 in the body:
- Low white blood cell count
- A certain type of anemia called megaloblastic anemia .If your doctor suspects vitamin B 12 deficiency , you can get vitamin B treatment to minimize the risk of these side effects .
- Headache and confusion (after completion of treatment)
- Dependent
- Cramps
How to store Niontix
This medicine does not require any special storage instructions regarding temperature, other than those applicable to gas containers and gas under pressure.
Do not smoke or use open flames in rooms where medical gases are stored.
Store the bottle in a locked and well-ventilated area reserved for medical gases.
Keep this medicine out of the sight and reach of children.
Store bottles under a roof, keep them dry and clean, free of oil and grease, and keep the space free of flammable materials.
Do not expose to strong heat.
Carried to safety in case of fire.
Precautions should be taken to prevent shocks or falls.
Bottles containing different types of gases must be stored separately.
Keep empty and full bottles separate.
Store and transport standing with the valve closed and the protective plug and cover fitted where such occurs.
Do not use this medicine after the expiry date which is stated on the bottle. The expiration date is the last day of the specified month.
Contents of the package and other information
Content declaration
- The active substance is nitrous oxide (nitrous oxide) 100% (Chemical name N 2 O)
- Niontix contains no other ingredients
What the medicine looks like and contents of the pack
The shoulder of the gas bottle is marked in blue (nitrous oxide). The body of the gas bottle is white (medical gas).
| Pack sizes in liters | 2.5 | 4 | 5 | 10 | 20 | 40 | 50 | 12×27 | 9×50 | 12×40 | 12×50 |
Not all pack sizes may be marketed.
Marketing Authorisation Holder:
| AGA Gas ABRotevägen 2SE-192 78 Sollentuna | Linde Gas ehfBreiðhöfði 11IS-110 Reykjavík |
Information is provided by
Linde Healthcare (a division within Linde Sverige AB)
Tel: 08-731 1000
This medicinal product is authorized under the European Economic Area under the names:
Denmark: NIONTIX, 100%, medical gas, liquid
Estonia: NIONTIX, 100%, meditsiiniline veeldatud
Finland: NIONTIX, 100%, lääkkeellinen kaasu, nesteytetty
Iceland: NIONTIX, 100%, liquefied petroleum gas, liquid
Latvia: NIONTIX, 100%, medical medicine, medicine
Lithuania: NIONTIX, 100% medicine, medicine, medicine
Norway: NIONTIX, 100%, medical gas, liquid