What is Budeflam 100 used for?
Xenon per anesthesia 100% (V / V)
|Pharmacological group||All other therapeutic means|
AIR LIQUIDE Medical GmbH
What is it and what is it used for?
1.1 Xenon pro anesthesia 100% (V / V) is an anesthetic gas.
What do you need to consider before use?
This medicine is not suitable for use in children under 18 years of age as there is no clinical experience.
There is no experience on the safety of the use of xenon in pregnancy and during obstetrics. If you are pregnant, Xenon pro Anaesthesia 100% (V / V) should only be used if your treating doctor considers this to be absolutely necessary.
It is not known whether xenon, the active ingredient in xenon pro anesthesia 100% (V / V), accumulates in breast milk. If you are breastfeeding, Xenon pro Anaesthesia 100% (V / V) should only be used if your treating doctor considers this to be absolutely necessary.
d) ability to drive and use machines
After anesthesia with xenon, you must not actively drive or use machines; The doctor has to decide individually about the time factor. You should only go home with someone.
How is it used?
Xenon pro Anaesthesia 100% (V / V) is only used by a doctor. Please contact your doctor if you have any questions about this.
3.1 Xenon is a partially liquefied gas that, in principle, may only be administered after it has evaporated (converted into a gaseous state) and with the help of suitable inhalation devices or anesthesia machines. Xenon may only be inhaled or artificially supplied to the lungs with an admixture of at least 30% oxygen. The application time depends on the duration of the anesthesia, but should not exceed 4-6 hours.
3.2 In general anesthesia, depending on the individual needs of the patient, the respective procedure and the dosage of the accompanying medication, concentrations of between 55% and 65% by volume xenon in the ventilation air are recommended.
What are the possible side effects?
Interactions with other drugs
The patient is requested to inform the doctor or pharmacist if other medicines are being taken / used or have recently been taken / used, even if they are medicines that are not available on a prescription.
In most cases, there is no reason to discontinue treatment with other necessary drugs before general anesthesia with xenon. It is sufficient if the anesthetist is informed about it.
Concomitant administration of xenon and the following drugs requires strict clinical monitoring of the patient:
Xenon has no muscle-relaxing effect. The effect of muscle relaxants is not affected by xenon.
Opioids and other central depressant drugs
The narcotic effect of xenon is increased by the simultaneous administration of opioid analgesics and other central depressant drugs as well as under hypothermia, so that low doses may be sufficient.
Alpha and beta sympathomimetics (e.g. adrenaline [administered by subcutaneous or gingival injections for the purpose of local hemostatic effect] and noradrenaline), beta sympathomimetics (orciprenaline)
In clinical studies with xenon, subcutaneous administration of 0.25 mg of adrenaline (50 ml of a dilution 1: 200,000) did not reveal any evidence of an increase in the frequency of ventricular arrhythmias.
Beta-blockers and other antihypertensive drugs
Cardiovascular compensatory responses can be impaired by beta-blockers (but this can be mitigated by administering beta sympathomimetics during surgery).
In general, treatment with beta-blockers and other antihypertensive drugs should not be discontinued and an abrupt dose reduction should be avoided.
Xenon can cause marked hypotension in patients who are treated simultaneously with calcium antagonists, especially those belonging to the dihydropyridine class.
Indirectly acting sympathomimetics (amphetamines and their derivatives, psychostimulants, appetite suppressants, ephedrine and its derivatives)
There is a risk of a perioperative increase in blood pressure. If surgery is planned, the treatment should preferably be discontinued a few days before the operation.
The influence of MAO inhibitors on xenon-based anesthesia is currently not known. Data on the simultaneous use of MAO inhibitors and Xenon pro Anesthesia 100% (V / V) are currently not available.
As with other inhalation anesthetics, treatment with MAO inhibitors should be discontinued 15 days before the operation to be on the safe side.
What side effects are possible?
Like all medicines, Xenon pro Anesthesia can cause 100% (V / V) side effects.
When evaluating side effects, the following frequencies are used as a basis:
more than 1 in 10 people treated
less than 1 in 10 but more than 1 in 100 patients
less than 1 in 100 but more than 1 in 1,000 people treated
Less than 1 in 1,000 but more than 1 in 10,000 people treated
1 or less in 10,000 people, including isolated cases
Increase in blood pressure above the norm
Nausea and vomiting after surgery
Drop in blood pressure below the norm
Slowing down of the heart rate
Increase in body temperature or sweating during or after the operation
Furthermore, the following has been observed in clinical studies without being directly related to xenon anesthesia:
Increase in liver function tests or white blood cells in the blood
Decrease in calcium or pH levels in the blood
Increased secretion of mucus
An increased tendency to bleed from the uterus during obstetric interventions cannot be ruled out, as no studies are currently available.
Since xenon may only be used under the responsibility of an anesthetist, the latter decides when side effects are treated symptomatically or when the supply of xenon is stopped.
4.3 The patient is requested to inform the doctor or pharmacist if he notices any side effects not listed in this package insert.
How should it be stored?
- Store drug out of reach of children.
- Do not use the medicine after the expiry date stated on the pressure bottle label.
- Store in the original container.
- Keep the container tightly closed.
- Protect the pressurized gas cylinder from direct sunlight and exposure to heat; secure against falling over.
- Do not store in stairwells, corridors, passageways and consumption rooms. In particular, the technical rule for compressed gases (TRG) No. 280 must be observed.
- All lines and fittings are to be kept free of oil and grease.
- Only original bottlings from the manufacturer may be used for medical purposes.
- The maximum permissible filling weight is stamped on the bottle shoulder.
- Pressure vessels for xenon must not be cleaned with toxic, sleep-inducing, anesthetic substances or the respiratory tract when using irritating substances.
- The primary container, the pressurized gas cylinder, is the property of the pharmaceutical company.
- The pressurized gas cylinders are taken back by the pharmaceutical company.
- Only empty up to a residual pressure of 3 bar in order to avoid contamination and to ensure reliable function even after refilling. A backflow is to be prevented (risk of penetration of water or moisture or foreign matter). Compliance with the residual pressure must be ensured.
Status of information:
Marketing Authorization Holder AIR LIQUIDE Deutschland GmbH
D - 40235 Düsseldorf
Tel .: 0211/6699 - 0
Fax: 0211/6699 - 222
manufactured by: AIR LIQUIDE Deutschland GmbH
Business premises: Krefeld-Gellep
D - Bataverstr. 47
Tel .: 02151/954 - 0
Fax: 02151/954 - 297
1.3 Xenon pro Anaesthesia 100% (V / V) is used in combination with other pain relievers or anesthetics to maintain anesthesia in adults. There is currently insufficient knowledge about the use of xenon per anesthesia 100% (V / V) in patients with coronary heart disease or other serious pre-existing diseases.
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Replace the displayed content Not the original package insert for the medicinal product, in particular with regard to the dosage and effect of the individual products. We cannot accept any liability for the correctness of the data, as some of the data was converted automatically. A doctor should always be contacted for diagnoses and other health issues. More information on this topic can be found here
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