PACKAGE LEAFLET: INFORMATION FOR THE USER
Medicinal nitrous oxide SIAD
Medicinal gas, liquefied Dinitrogenii oxidum
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 pharmacist. - 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 pharmacist. This includes any possible side effects not listed in this leaflet. See section 4.
What is in this leaflet: 1. What Medicinal nitrous oxide SIAD is and what it is used for 2. What you need to know before you take Medicinal nitrous oxide SIAD 3. How to take Medicinal nitrous oxide SIAD 4. Possible side effects 5. How to store Medicinal nitrous oxide SIAD 6. Content of the pack and other information
1. WHAT MEDICINAL NITROUS OXIDE SIAD IS AND WHAT IT IS USED FOR
The medicinal substance is nitrous oxide (dinitrogenii oxidum) 100% by volume, medicinal gas, liquefied.
No other substances are present in the product Medicinal nitrous oxide SIAD.
Medicinal nitrous oxide SIAD is a colorless gas of sweetish smell. It is used for inhalation. It is supplied as liquefied gas in the gas cylinder.
Nitrous oxide relieves pains (it exerts analgesic effects) and has narcotizing (anaesthetic) effects.
The effect of nitrous oxide occurs due to affecting a number of chemical substances, so called neurotransmitters, which act as signal substances transferring information within the nervous system.
1
Medicinal nitrous oxide SIAD is used: - for artificial sleep (anaesthetic agent) in the introduction to general anaesthesia and for its maintenance over the period of a medical intervention in combination with other anaesthetics administered intravenously or by inspiration (inhalation), - for alleviation of pain and for calming (as analgesic/sedative), where the alleviation is desirable with rapid onset and with avoiding long-term persistence of the analgesic effect.
Medicinal nitrous oxide SIAD may be administered to children and adults.
2. WHAT YOU NEED TO KNOW BEFORE YOU USE MEDICINAL NITROUS OXIDE SIAD
Do not use Medicinal nitrous oxide SIAD/the product should not be administered to you:
if you have the signs of increased pressure inside the skull if you are unconscious in the case of pneumothorax in disease with predicted gas accumulation in cavities (e.g. in gut, nasal cavities) in the case of pneumonic hypertension (elevated pressure) in the case of lack of vitamin B12 in the case of head injuries with unconsciousness in the case of injury in your face in the case of caisson disease (decompression sickness) in strongly suppressed individuals in current therapy by methotrexate
Warnings and precautions Talk to your doctor before using Medicinal nitrous oxide SIAD
- if you suffer from a lack of vitamin B12, since the medicinal nitrous oxide can cause an aggravation of this lack. - if you suffer from cardiac insufficiency or severe heart dysfunction nitrous oxide must be administered with caution - nitrous oxide should not be used during the laser surgery in airways due to risk of explosive burning - nitrous oxide induces increasing the middle ear pressure - nitrous oxide may cause loss of laryngeal reflexes and loss of consciousness in higher
2
concentrations - risk of hypoxaemia may be after total anaesthesia. Respiratory functions and the signs of intoxication will be monitored. - have or have had drug/medication abuse because there is a higher risk of developing dependence to nitrous oxide if you take it repeatedly. Your doctor will decide whether treatment with Medicinal nitrous oxide SIAD is possible in your case.
Repeated or long-term use of nitrous oxide may increase the risk of vitamin B12 deficiency which may lead to damage of the bone marrow or the nervous system. Your doctor may initiate blood tests before and after the treatment in order to assess the consequences of the possible vitamin B12 deficiency.
Other medicines and Medicinal nitrous oxide SIAD
Tell your doctor if you are taking, have recently taken or might take any other medicines.
Total anaesthetics, sedative drugs, analgesics Nitrous oxide in combination with other inhalation anaesthetics increases its effect and reduces the lot size of required dose. It enhances also the effect of intravenous anaesthetics, sedative drugs and analgesics and thus leads to their doses reduction.
Local anaesthetics
N2O increased analgesic effect of local anesthetics used for local anaesthesia of mandibula (jaw bone) and also on the level of subarachnoid anaesthesia.
Methotrexat
N2O acts by the same way as methotrexate. The animal experiments demonstrated that chemotherapeutic effects of methotrexat are increased so as its toxicity.
N2O acts by the same way as non-depolarizing myorelaxans (the drugs which release muscles).
Pregnancy, breast-feeding and fertility Pregnancy 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. It is not recommended to use the nitrous oxide during the first two trimesters of pregnancy. Breast-feeding Medicinal nitrous oxide SIAD may be used in breast-feeding women.
3
Driving and using machines Medicinal nitrous oxide SIAD affects the mental functions. If Medicinal nitrous oxide SIAD is used as an only substance for pain relief and calming, driving vehicles and handling with machinery is not recommended for at least 30 min after completing its administration or till a complete recovery is achieved. After anesthesia with Medicinal nitrous oxide SIAD, driving of motor vehicles is not recommended for a period of 24 h after its administration.
3. HOW TO TAKE MEDICINAL NITROUS OXIDE SIAD
Always take Medicinal nitrous oxide SIAD by inhalation (inspiration) only, exactly as your doctor has told you. Check with your doctor if you are not sure. The medicinal nitrous oxide should be administered by healthcare professionals, who master appropriate knowledge about the use of this medicinal gas.
Medicinal nitrous oxide may only be administered, if there is immediately available equipment for providing patent airways and initiating the recovery of vital functions (resuscitation).
Medicinal nitrous oxide is usually inspired through an unaesthetic mask, the breathing being either independent - spontaneous - or provided by controlled ventilation. It is always administered as a gaseous mixture comprising at least 21% oxygen by volume to prevent oxygen insufficiency (so called “hypoxia”).
Medicinal nitrous oxide may only be administered in rooms with appropriate ventilation and/or with instrumentation preventing the production of excess nitrous oxide concentration in surrounding atmosphere, which could affect the personnel and further persons present in the vicinity of the patient administered.
Dosage - in pain and for calming (analgesia/sedation)
Medicinal nitrous oxide inspired at concentrations up to 50% relieves the pain and brings sedation without disturbing consciousness and with saving reactions to verbal communication.
Breathing, blood circulation and protective reflexes are usually safely maintained at these concentrations.
- for artificial sleep (anaesthesia)
4
For anaesthesia, medicinal nitrous oxide concentrations between 35% and 75% are used in combination with other anaesthetics since the effects of nitrous oxide alone are very weak to induce narcosis.
If you take more Medicinal nitrous oxide SIAD than you should If you were administered with too much Medicinal nitrous oxide SIAD, you can become hypoxic, which means that you have a lack of oxygen in your blood. Hypoxia should be definitely prevented, since it can result in affecting body function and cause unconsciousness.
If too much Medicinal nitrous oxide SIAD is administered, then the administration must be stopped or the concentration administered must be reduced. If there is a suspect lack of oxygen in the blood, it is necessary to inspire fresh air. In medical institutions, oxygen must be administered with continuous monitoring of oxygen levels in the blood with the use of pulsed oxymeter. Oxygen must be administered till the recovery is achieved and the blood is sufficiently saturated with oxygen.
You will be administered with the product in medical institutions under careful surveillance and thus, overdose is not likely to occur.
Safety directions
Medicinal nitrous oxide SIAD is exclusively designed for inhalation in agreement with instructions by doctor. Always attach equipment designed for joining medicinal nitrous oxide only. Like all anesthetic gases, medicinal nitrous oxide needs appropriate ventilation of sites, where it is used. Nitrous oxide is a gas supporting burning, heavier than air. In general it is recommended that specialists using medicinal nitrous oxide should avoid direct inhalation of air expired by patients, if the work takes a longer time. The gas cylinders must not be exposed to excess heat. In rooms, in which Medicinal nitrous oxide SIAD is used, smoking and use of open flame is prohibited because of enhanced risk of fire. Never use lubricants, oil or similar substances for lubrication of blocked threads. Open the pressure regulator slowly and carefully. Handle the gas cylinder with care. Be sure that it is not exposed to shaking and cannot fall. In the case of taking the product Medicinal nitrous oxide SIAD, the gas cylinder must be situated in the upright position with the pressure regulator up. Medicinal nitrous oxide is taken from the gas cylinder in gaseous phase by the action of pressure, but it is liquid inside of the cylinder In the case of situation of the gas cylinder in horizontal position, the liquid could escape and cause damage. The pressure regulator must be slowly and
5
carefully opened to prevent the release of liquid nitrous oxide. Keep the gas cylinder clean and dry. The gas cylinder must be kept and transported with closed valve equipped with a protective cover.
4. POSSIBLE SIDE EFFECTS - Like all medicines, Medicinal nitrous oxide SIAD can have side effects, although not everybody gets them. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
The following side effects were most typically observed:
Common (may affect up to 1 in 10 patients): Gastrointestinal disorders: - feeling sick and vomiting, Psychiatric disorders: - abnormally good mood, anxiety condition, dizziness or faints, Blood and lymphatic system disorders: - reduced saturation of the red blood pigment with oxygen in children. Uncommon (may affect up to 1 in 100 patients): Gastrointestinal disorders: - flatulence, Ear and labyrinth disorders: - feeling pressure in the middle ear. Rare (may affect up to 1 in 1,000 patients): Cardiac disorders: - heart rhythm disorders, pulmonary hypertension, hypotension in newborns, Blood and lymphatic system disorders: - in the case of administration exceeding a period of 24 h - reduced count of red blood
cells caused by insufficiency of vitamin B12 and/or folic acid, reduced count of white blood cells, Nervous system disorders: - non-inflammatory disease of the medulla, non-inflammatory disease of multiple nerves, increased intracranial pressure (pressure in the skull), cramps, headache, Respiratory, thoracic and mediastinal disorders: - temporary breathing arrest, narrowing of the bronchi.
6
Not known (cannot be estimated from the available data) Nervous system disorders: - generalised seizures - effects on nerve function, sensations of numbness and weakness, usually in the legs Psychiatric disorders: - addiction
Reporting of side effects If you get any side effects, talk to your doctor or pharmacist. 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 MEDICINAL NITROUS OXIDE SIAD
Keep this medicine out of the sight and reach of children.
Keep gas cylinders in appropriately ventilated rooms designed for the storage of medicinal gases.
The gas cylinders should be stored under the roof, protected from atmospheric effects and wind, kept dry and clean, free of flammable materials.
Temperatures of -20 to +40°C are recommended for long-term storage. The cylinders may be exposed for a short period to temperatures up to +60 °C.
Precautions should be provided to prevent shaking and falling.
Gas cylinders containing different species of gases must be kept separately. Full and empty cylinders must be kept separately.
Transportation of bottled gas
Gas cylinders must be transported with the use of suitable material protecting them from dangerous impacts and falls and maintaining them in the upright position.
6. CONTENTS OF THE PACK AND OTHER INFORMATION
Packaging
7
Volume of Dinitrogenii Cylinder/cylinder Valve type and Cylinder Charge weight in oxidum (nitrous bundle capacity material material [kg] oxide) in [litre] at in [litres] of water pressure 1 bar and temperature 15 C 10 Closing valve of steel 7.5 4,050 chrome-platted brass 40 Closing valve of steel 30 16,200 chrome-platted brass 50 Closing valve of steel 37.5 20,250 chrome-platted brass Cylinder bundle Closing valve of Steel, 600 324,000 16 x 50 l chrome-platted brass interconnection (800 l) of cylinders by stainless pipeline
Note: outlet closing valve screwing has a G3/8´´ thread
Colour marking White body of the cylinder with blue top rounded part of the cylinder marked with two white letters “N” situated against each other.
Marketing Authorisation Holder:
[ To be completed nationally]
Manufacturer: SIAD Czech spol. s r.o. U Sýpky 417 Rajhradice 664 61 Czech Republic
For information about the Medicinal nitrous oxide SIAD contact:
SIAD Czech spol. s r.o. K Hájům 2606/2b Praha 5 - Stodůlky
8
155 00 Czech Republic Tel.: +420 235 097 520 Fax: +420 235 097 525
This leaflet was last revised in :
The following information is intended for healthcare professionals only: Repeated administration or exposure to nitrous oxide may lead to addiction. Caution should be excercised in healthcare professionals with occupational exposure to nitrous oxide.
9