WAG-Münster Conoclin O DE/H/3064/001/II/002 Variation – Day 55 Package Leaflet Jan. 2012 – page 1
PACKAGE LEAFLET: INFORMATION FOR THE USER
Conoclin O 100% v/v medicinal gas, cryogenic Active substance: Oxygen
Read all of this leaflet carefully because it contains important information for you. This product is available without prescription. However, you still need to use Conoclin O carefully to get the best results from it. Keep this leaflet. You may need to read it again. Ask your doctor or pharmacist if you need more information. You must contact a doctor if your symptoms worsen or do not improve. If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
In this leaflet: 1. What Conoclin O is and what it is used for 2. Before you use Conoclin O 3. How to use Conoclin O 4. Possible side effects 5. How to store Conoclin O 6. Further information
1. WHAT CONOCLIN O IS AND WHAT IT IS USED FOR
Conoclin O contains oxygen, a gas that is essential for life. Pharmacotherapeutic group : Medical Gases.
The product can be used as a respiratory aid under normal pressure and under high pressure.
Oxygen therapy at normal pressure (normobaric oxygen therapy)
Oxygen therapy at normal pressure can be used: if the oxygen concentration of the blood or of a specific organ is too low, or to prevent it from becoming too low. for patients with insufficient or disturbed breathing who depend on low oxygen concentration (hypoxia) as a breathing stimulus. for treatment of patients with cluster headache.
Oxygen therapy at high pressure (hyperbaric oxygen therapy)
Oxygen therapy at high pressure (hyperbaric oxygen therapy) should only be administered by qualified staff, in order to avoid the risk of injury due to strong fluctuations in pressure.
Oxygen therapy at high pressure can be used: for the treatment of serious carbon monoxide poisoning (e.g., when the patient is unconscious). for the treatment of the bends (decompression disease). for the treatment of an obstruction in the heart or blood vessels caused by bubbles (gas or air embolism). for the support treatment in cases of bone loss after radiotherapy (osteoradionecrosis). for the support treatment in cases of dying tissue as a result of an injury infected with gas- producing bacteria (clostridial myonecrosis, gas gangrene).
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2. BEFORE YOU USE CONOCLIN O
Do not use Conoclin O Conoclin O at high pressure must not be used in cases of a slap lung, for which you have not yet been treated (untreated pneumothorax). A slap lung is an accumulation of air or gas in the thoracic cavity between the two pulmonary membranes. If you have ever had a slap lung, please let your doctor know.
Take special care with Conoclin O Before you start the oxygen therapy you should know the following: Oxygen may have harmful effects at high concentrations. This may cause the alveoli to collapse, which will obstruct the oxygen supply to the blood. This can happen when using a concentration of 100% for more than 6 hours, 60 to 70% for more than 24 hours, 40 to 50% for a second 24-hour period, and a concentration of over 40% for more than 2 days. Be extra careful in new-born infants and pre-term new-born infants, to minimise the risk of adverse events such as eye damage. Also be extra careful if you have a raised carbon dioxide level in your blood, because in extreme cases this may lead to loss of consciousness. Patients with breathing disorders who depend on low oxygen concentration (hypoxia) as a breathing stimulus need to be closely monitored by their doctor.
When using oxygen therapy at high pressure (hyperbaric oxygen therapy) you should contact your doctor when one of the following occurs: chronic obstructive pulmonary disease (COPD) a disorder of the lungs due to the loss of elasticity of lung tissue accompanied by (serious) shortness of breath (lung emphysema) infections in the upper respiratory tract insufficient controlled asthma bronchiale recent middle ear surgery thoracic surgery at any time uncontrolled high fever convulsions (insufficient controlled epilepsy) fear of confined spaces (claustrofobia) if you have ever had a slap lung (which is an accumulation of air or gas in the thoracic cavity between the two pulmonary membranes (pneumothorax)).
Children In pre-term and new-born infants oxygen therapy may lead to a certain eye damage (retrolental fibroplasia). By appropriate choice of the oxygen concentration by the treating physician the risk of this eye damage can be reduced. The efficacy and safety of oxygen in the treatment of cluster headache has only been investigated in adults. There is no data for the use in children under 18 years.
Advice Oxygen is an oxidising product and promotes combustion. The liquid oxygen in the container is under pressure (0-10 bar). Oxygen becomes a fluid at approximately -183°C. There is a risk of burns at such low temperatures. Always wear gloves and protective goggles when working with medicinal liquid oxygen.
Using other medicines Please tell your doctor or pharmacist if you are using/taking or have recently used/taken any other medicines, including medicines obtained without a prescription.
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The administration of oxygen may increase or decrease the desirable or undesirable effects of certain other types of medicinal products. Please consult your doctor or pharmacist for more information. Amiodarone (a medicinal product used to treat cardiac arrhythmia): there have been reports of interaction. Bleomycin or actinomycin (anti-cancer medicinal products) and the pesticide Paraquat: previous pulmonary damage caused by these products may exacerbate as a result of oxygen therapy, possibly with fatal consequences. The following medicinal products may increase the harmful effects of oxygen: o Adriamycin (anti-cancer medicinal product). o Menadion (a medicinal product used to reduce the effect of anti-coagulants). o Promazine, Chloropromazine and Thioridazine (medicinal products used to fight serious mental disorders that cause patients to lose control over their behaviour and actions (psychosis)). o Chloroquine (an anti-malarial drug). o Corticosteroids (hormones such as cortisol, hydrocortisone, prednisolone and many others), drugs that stimulate specific parts of the nervous system (sympathicomimetics).
Oxygen therapy may have other effects: Previously treated oxygen radical damage to the lungs, for example in the treatment of paraquat poisoning. Oxygen therapy may exacerbate this lung damage. The harmful effects of oxygen may increase in patients who suffer from a lack of vitamin C, E or glutathione. The harmful effects of oxygen may be increased by X-rays. The harmful effects of oxygen may increase in patients with an overactive thyroid.
Using Conoclin O with food and drink Do not drink any alcohol during oxygen therapy. Alcohol can suppress the breathing.
Pregnancy and breast-feeding During pregnancy, the use of oxygen under normal pressure (normobaric oxygen therapy) is permitted in low concentrations, if used properly and controlled by your doctor. By way of life-saving treatment, oxygen can also be used during pregnancy in high concentrations and at high pressure. There are no objections to the use of oxygen during breast-feeding.
Ask your doctor or pharmacist for advice before taking any medicine.
Driving and using machines Oxygen therapy does not cause any reduction of the attentiveness during driving and using machines.
3. HOW TO USE CONOCLIN O
Always use Conoclin O exactly as your doctor has told you , in particular with regard to the volume flow and the duration of the treatment. Do not stop the treatment prematurely; it is possible that oxygen use will have to continue for a long period. You should check with your doctor or pharmacist if you are not sure.
Dosage The oxygen administration should be individually adapted to the particular clinical condition. Generally the oxygen supply should be adjusted as low as possible. The necessary volume of oxygen is determined by regularly controls (e.g. by pulse oxymetry and/or blood gas analysis), which are performed by your doctor or are initiated at the hospital. Generally an oxygen administration of 2 – 4 l/min is recommended.
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Oxygen therapy at normal pressure (normobaric oxygen therapy) if the oxygen concentration of the blood or of a specific organ is too low, your doctor will tell you for how long and how many times a day you should administer Conoclin O. The aim is always to use the lowest possible oxygen concentration that is still effective. However, the actual oxygen concentration for inhalation should never be less than 21%, and may be increased up to 100%.
In case of insufficient or disturbed breathing and dependence on low oxygen concentration (hypoxia) as a breathing stimulus, (e.g. in pulmonary diseases with airway narrowing and prolonged symptoms such as coughing, chronic shortness of breath and mucus production (COPD) the effective oxygen concentration will be kept below 28% and sometimes even lower than 24%. In the case of new-born infants, effective oxygen concentrations of over 40% for inhalation are avoided and only in very exceptional cases raised to 100%.
In the case of cluster headache, 100% oxygen is administered at a flow rate of 7 litres/minute for 15 minutes using a close-fitting facial mask. The treatment should begin in the earliest stage of a crisis.
Route of administration: inhalation use
Normal pressure Conoclin O is a gas for inhalation that is administered through inhaled air using special equipment, such as a nose catheter or a facial mask. If you cannot breathe independently, you will be put on artificial breathing by an endotracheal tube.
High pressure Oxygen therapy at high pressure should only be administered by qualified staff, in order to avoid the risk of injury due to strong fluctuations in pressure. Depending on your condition, oxygen therapy under high pressure is administered at a pressure of 1.4 to 3.0 atmosphere, and lasts 45 to 300 minutes per treatment session. The therapy sometimes only lasts one or two sessions, but long-term therapy can take up to 30 sessions or more, and multiple sessions a day if necessary. Oxygen therapy at high pressure is given in a special pressure room especially designed for oxygen therapy at high pressure, where the pressure can be maintained at up to three times the atmospheric pressure. Oxygen therapy at high pressure can also be provided using a close-fitting facial mask with a hood covering the head, or through a tracheal tube.
If you use more Conoclin O than you should If you are coughing or can only hardly breathe, this might be a symptom of the oxygen pressure being adjusted to high. Please check the adjustment of the oxygen supply. If a greater amount of oxygen has been administered or has been adjusted mistakenly, than agreed with the doctor. Please talk to the doctor who is treating you and gradually reduce the oxygen concentration to the originally chosen value after consultation.
The toxic effects of oxygen vary according to the pressure of the inhaled oxygen and the duration of exposure. At low pressure (0.5 to 2.0 bar), these effects are more likely to occur in the pulmonary region than in the central nervous system (brain and spinal cord). At higher pressure (hyperbaric oxygen therapy), the opposite applies. The effects in the pulmonary region include shortness of breath (hypoventilation), coughing and chest pain. The effects in the central nervous system include nausea, dizziness, anxiety and confusion, muscle cramp, loss of consciousness, and epileptic fits.
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If you forget to use Conoclin O Use the oxygen when you remember. Do not use a double dose to make up for a forgotten dose, because medicinal oxygen may be harmful in high concentrations.
If you stop using Conoclin O Do not stop using the product on your own initiative. Always consult with your doctor first.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
4. POSSIBLE SIDE EFFECTS
Like all medicines, Conoclin O can cause side effects, although not everybody gets them.
The side effects have been grouped according to therapy.
Oxygen therapy at normal pressure (normobaric oxygen therapy) may result in: a slight reduction in pulse, and in heart failure shortness of breath, as a result of problems in the exchange of gases due to obstruction of the respiratory tract (hypoventilation) or to collapse of the alveoli (atelectasis) chest pain fatigue
In patients with breathing disorders who depend on low oxygen concentration (hypoxia) as a breathing stimulus, the administration of oxygen may further reduce breathing effectiveness, and can result in an accumulation of carbon dioxide and excessive acid in the body (acidosis).
In new-born infants and pre-term new-born infants the administration of oxygen may result in eye damage, malformations of the lungs, bleeding in the heart, brain or spinal cord, and in inflammation of the stomach and intestines (gastroenteritis) with local death of cells in a tissue (necrosis) and perforations. You should notify your doctor about even the smallest change in the babies’ medical condition.
Oxygen therapy at high pressure (hyperbaric oxygen therapy) may result in: temporary loss of eyesight nausea dizziness anxiety and confusion muscle cramp loss of consciousness epileptic fits damage to the middle ear caused by pressure fluctuations damage to the lungs caused to pressure fluctuations (pulmonary barotrauma) pain, possibly accompanied by inflammation and bleeding in the paranasal sinuses caused by pressure fluctuations aching muscles
These side effects may disappear in the course of time.
If any of the side effects gets serious or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist.
5. HOW TO STORE CONOCLIN O
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Keep out of the reach and sight of children. Do not use Conoclin O after the expiry date which is stated on the label of the cryogenic vessel after EXP. The shelf-life or duration of use respectively is limited due to technical reasons and depends on the size and type of the container. The quality is guaranteed throughout the limited duration of use of one container filling.
Do not store above 50 °C. Keep the vessels tightly closed in order to protect from moisture. The container must be stored in a well ventilated area. Make sure that no inflammable products are store near the container. Make sure that sources of heat or flames do not come near the container. Do not smoke near the container. Transport should be performed in accordance with the regulations for the transport of dangerous goods.
6. FURTHER INFORMATION
What Conoclin O contains The active substance is oxygen. 1.00 l gas (cryogenic at -183 °C) contains 1.141 kg oxygen (corresponding to 100% v/v). 1.00 l cryogenic oxygen corresponds to 0.854 m3 gaseous oxygen at 15 °C and 1 bar.
There are no other ingredients.
What Conoclin O looks like and contents of the pack Conoclin O is a medicinal gas and in its cryogenic form it looks like a clear, light blue liquid. Conoclin O is available in mobile cryogenic vessels and in fixed cryogenic vessels. These are mobile or static thermally insulated containers designed to maintain the content in a liquid state. Oxygen is delivered as a liquid with a very low temperature (approx. – 183 °C).
Mobile cryogenic vessels: Range of sizes (nominal capacity) [l] Extractable (gas)volume [m3] (1 bar / -183 °C) (1 bar / 15 °C) corresponds to a nominal volume of 175 l – 600 l (relating to a filling level of 95%) from up to from ca. up to ca. 175 180 142 146 180 230 146 187 230 450 187 365 450 666 365 540
Fixed cryogenic vessels: Range of sizes (nominal capacity) [l] Extractable (gas)volume [m3] (1 bar / -183 °C) (1 bar / 15 °C) corresponds to a nominal volume of 1,000 l – 78,000 l (relating to a filling level of 95%) from up to from ca. up to ca. 989 1500 802 1217 1500 2000 1217 1623 2000 3000 1623 2434 3000 5000 2434 4057 5000 6000 4057 4868
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6000 7000 4868 5679 7000 8000 5679 6490 8000 9000 6490 7302 9000 10000 7302 8113 10000 12000 8113 9736 12000 20000 9736 16226 20000 30000 16226 24339 30000 41000 24339 33263 41000 50000 33263 40565 50000 60000 40565 48678 60000 78000 48678 63281
Marketing Authorisation Holder Westfalen AG Industrieweg 43, 48155 Münster, Germany +49 (0) 251 695 0; +49 (0) 251 695 194 [email protected]
Manufacturer Westfalen AG Industrieweg 43, 48155 Münster, Germany
Westfalen AG Nobelstraße 5, 48477 Hörstel, Germany
Westfalen AG Rudolf-Diesel-Straße 17, 89150 Laichingen, Germany
Westfalen AG Daimlerstraße 35, 89264 Weißenhorn, Germany
Westfalen AG Ludwig-Lange-Straße 4, 67547 Worms, Germany
This medicinal product is authorised in the Member States of the EEA under the following names: Germany Conoclin O The Netherlands Conoclin O 100% v/v, medicinaal gas, cryogeen
This leaflet was last approved in {MM/YYYY}.
The following information is intended for medical or healthcare professionals only:
Special caution is required by the use of cryogenic oxygen. Only authorised personal should be allowed in the area of the Container-Vaporiser-Facilities – it is referred to the relevant safety requirements for the handling of cryogenic oxygen.
Oxygen strongly promotes combustion, this is why combustible substances should be kept away from the vessels for cryogenic oxygen. If clothing is enriched with oxygen, the risk of accidents is increased.
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Accumulation of oxygen in closed rooms increases the danger of fire. Smoking and fire are prohibited, possible ignition sources should be eliminated. The rooms need to be ventilated intensively.
Cryogenic oxygen can cause frostbites or cold burns respectively when taken from vessels inappropriately; especially the eyes can be harmed by splashes. Therefore appropriate protective clothing must be worn (gloves, safety goggles, not tight-fitting clothing and trousers, which cover the shoes). In case of contact of cryogenic oxygen with the skin or the eyes, these areas have to be treated with large amounts of cold water or cold compresses immediately.
If cryogenic oxygen is taken of vessels for cryogenic gases it must be ensured, that cryogenic oxygen does not come into contact with unsuited materials for oxygen (for example rubber hoses or pipes of steel). By pouring of cryogenic oxygen in smaller sized cryo-containers the operating instructions of manufacturer of those containers must be followed.
Only valves and other equipment approved for oxygen must be used. All valves, downstream lines instruments and devices must be free of oil and grease.
A return flow or the intrusion of water (humidity) in the vessels for cryogenic oxygen must be prevented.
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