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What Suprane is and what it is used for
Suprane contains desflurane. Suprane is a drug for anesthesia used in surgical procedures. It is an inhalation anesthetic (it is given as a vapor you inhale). By inhaling Suprane, you sleep deeply and feel no pain. Suprane also maintains a deep, pain-free sleep (anesthesia) so that you can undergo a surgical procedure. In adults, Suprane is used to initiate and maintain anesthesia, and in children only to maintain anesthesia.
What you need to know before you receive Suprane
Your anesthetist will not give you Suprane:
- if you are allergic (hypersensitive) to desflurane or other inhalation anesthetics such as isoflurane, sevoflurane, halothane, or enflurane.
- if you have previously had unexplained liver problems with jaundice, fever, and elevated levels of a certain type of white blood cell following anesthesia with desflurane or other anesthetics such as isoflurane, sevoflurane, halothane, or enflurane.
- if you or a relative of yours suffers from a condition called malignant hyperthermia. Malignant hyperthermia is a sudden and dangerous increase in body temperature during or shortly after a surgical procedure. Deaths from malignant hyperthermia have been reported with desflurane.
In children, the anesthesiologist will not give Suprane to induce anesthesia because coughing, respiratory arrest, respiratory arrest, laryngospasm (spasm of the muscles of the larynx, preventing air from passing through), and increased salivation are common.
Suprane should only be given by healthcare professionals trained in general anesthesia and under the supervision of an anesthesiologist.
Warnings and precautions
Talk to your doctor or nurse before you receive Suprane. The doctor will be extra careful when treating with this medicine if:
- if you have a reduced blood volume. Your doctor may need to give you treatment to restore your blood volume before you are put to sleep.
- if you have an injury or pathological change in the brain, e.g. a brain tumor.
- if you develop malignant hyperthermia (a sudden and dangerous increase in body temperature during or shortly after a surgical procedure), which is rare and unpredictable. In this case, your anesthetist will stop giving Suprane. To treat malignant hyperthermia, you will be given a medicine called dantrolene and other supportive care.
- if you have a neuromuscular disease (such as Duchenne muscular dystrophy). You may then be more sensitive to the rare increases in blood potassium levels that Suprane can cause.
- if you have been given an anesthetic by inhalation before, especially if this was given repeatedly recently.
- if you have low blood pressure.
- if you have coronary artery disease (a disease of the blood vessels that surround the heart and supply the heart muscle with oxygen). Your doctor may then need to give you other medicines.
- if you have or have previously had liver problems such as hepatitis (inflammation of the liver) or cirrhosis (a condition where the liver cells are successively replaced by connective tissue cells, causing the liver to lose function).
- if you have a certain type of change in the heart that can affect the heart rhythm (so-called “QT prolongation”, can be seen on the ECG ).
- if you have abnormally low levels of potassium in your blood
If you feel pain after you wake up from the anesthesia, your doctor will give you pain medication.
Contact a doctor as soon as possible if you experience unexplained muscle pain, muscle cramps, or muscle weakness.
Children
In children (especially children 6 years of age or younger), Suprane should not be given via a mask during the maintenance of anesthesia because it increases the risk of side effects in the respiratory tract such as coughing and laryngospasm (spasm in the muscles of the larynx which prevents air from the pass), see also section Side effect ar. The doctor will instead give Suprane via a throat tube that is inserted into the trachea. When a mask is used for children, the doctor will be extra careful and remove the mask only when the child is fully awake. Talk to the anesthesiologist if your child has asthma or has recently had an infection in the airways. The anesthetist will then be extra careful because there is then a risk that the airways will become narrower and that the resistance in the airways will increase.
In children, awakening from anesthesia can induce a brief state of irritation that can make a cooperation with doctors and nurses difficult after awakening.
Other medicines and Suprane
Tell your doctor or pharmacist if you are taking, have recently taken, or might take any other medicines.
The medicines or active substances included in medicines, listed below can affect each other’s effect when they are used together with Suprane. Some of these medicines are given to you by the anesthetist during the surgical procedure, as stated in the description.
- Nitrous oxide (nitrous oxide): This is a drug used in general anesthesia that induces sleep and relieves pain.
- Depolarizing and non-depolarizing muscle relaxants (for example, pancuronium, atracurium, suxamethonium, and vecuron): These drugs are used under general anesthesia to make your muscles relax.
- Tranquilizers (for example, fentanyl and midazolam)
- Calcium-blocking drugs (for example, verapamil). These are drugs that are often given to treat high blood pressure or irregular heart rhythms.
- Beta-receptor blocking agents, (eg propranolol). These are heart medications that are often given to treat high blood pressure.
- Medicines that can cause QT prolongation (a heart problem that can affect the heart rhythm, can be seen on the EKG ).
Pregnancy and breastfeeding
If you are pregnant or breastfeeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before you are given this medicine.
You should not be given Suprane if you are pregnant or breastfeeding.
Driving ability and use of machinery
Suprane has a strong influence on your ability to drive and use tools or machines. Do not drive or use tools or machines until your doctor tells you it is safe.
You are responsible for assessing whether you are fit to drive a motor vehicle or perform work that requires increased attention. 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. Description of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. Discuss with a doctor or pharmacist if you are unsure.
How to get Suprane
Suprane is given to you by an anesthesiologist. The anesthetist will decide how many doses you need and when you will receive it. The dose varies depending on your age, the type of surgery you are having, and the other medications you are taking during the surgery.
Suprane is made from liquid desflurane using a gasifier specifically designed to be used for desflurane. You may be asked to breathe in desflurane gas through a mask to put you to sleep. You may also receive an injection of another anesthetic to put you to sleep before receiving desflurane through a mask or a so-called nasopharyngeal tube.
During the anesthesia, your doctor will check your blood pressure and heart rate to determine if your dose needs to be adjusted.
The anesthetist will decide when it is time to stop giving you Suprane. You will then wake up after a few minutes.
Use for children
If your child is under 6 years of age, she/he will first be given another anesthetic to put them to sleep, and then the anesthetist will give Suprane via a nasogastric tube.
If you have received too much Suprane
Suprane will be given by a healthcare professional and it is unlikely that you will be given too much Suprane. If you should still receive too much Suprane, the anesthesiologist will take the necessary measures.
Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them.
Very common (affects more than 1 in 10 users)
- Vomiting. This side effect has been reported during induction and maintenance of anesthesia with Suprane.
- Nausea. This side effect has been reported during induction and maintenance of anesthesia with Suprane.
Common (affects 1 to 10 users in 100):
- Inflammation of the throat ( pharyngitis )
- Headache
- Inflammation of the conjunctiva of the eye
- Irregular heartbeats ( nodular arrhythmia )
- Slow heartbeat
- Palpitation
- Increased blood pressure
- Temporary, transient cessation of breathing ( apnea ). This side effect has been reported during induction and maintenance of anesthesia with Suprane.
- Cough. This side effect has been reported during induction and maintenance of anesthesia with Suprane.
- Spasm of the muscles of the larynx, which prevents air from passing ( laryngospasm ). This side effect has been reported during induction of anesthesia with Suprane.
- Increased salivation. This side effect has been reported during induction and maintenance of anesthesia with Suprane.
- Elevated levels of the enzyme et creatinine phosphokinase
- A certain type of change in the heart can affect the heart rhythm (so-called “QT prolongation”, can be seen on the EKG ).
Uncommon (affects 1 to 10 users in 1,000):
- Motor restlessness, restless and excessive movements ( agitation )
- Dizziness
- Myocardial infarction
- Lack of oxygen in the heart muscle (myocardial ischemia )
- Irregular heart rhythm ( arrhythmia )
- Widening of blood vessels
- Oxygen deficiency. This side effect has been reported during induction and maintenance of anesthesia with Suprane.
- Muscle pain
Has been reported (occurring in an unknown number of users):
- Coagulation disorder (disorder in the clotting ability of the blood)
- Too high a level of potassium in the blood
- Too low level of potassium in the blood
- Lowered pH in the body is caused by high levels of acidic substances
- Cramps
- Cardiac arrest
- An unusual form of arrhythmia where the heart beats very fast ( Torsade de pointes )
- The chambers of the heart stop working
- Impaired movement in the chambers of the heart with abnormally small or slow movements
- Atrial fibrillation (a form of heart rhythm disorder due to irregular activation of the front chamber of the heart, the atria, causing the heart to contract at irregular intervals)
- Very high blood pressure ( malignant hypertension )
- Bleeding
- Low blood pressure
- Shock. A life-threatening condition that occurs when blood pressure drops and circulation decreases
- Breathing stops working as it should and the body, therefore, does not get a normal supply of oxygen and elimination of carbon dioxide.
- Respiratory distress
- Spasms in the muscles of the trachea can make it harder to breathe. Common symptoms are wheezing, and wheezing.
- Inflammation of the pancreas
- Stomach pains
- Impaired or insufficient liver function (liver failure)
- Tissue death in the liver
- Inflammation of the liver ( hepatitis and cytolytic hepatitis )
- Bile stasis (blockage of bile flow to the intestine)
- Jaundice (yellowing of the skin and whites of the eyes)
- Abnormal liver function
- Liver disorder
- Hives or hives. The symptoms are redness, swelling, and strong itching.
- Redness of the skin
- Dissolution of muscle tissue with precipitation of myoglobin as a result, can lead to acute kidney failure ( rhabdomyolysis ).
- A sudden and dangerous rise in body temperature during or shortly after a surgical procedure ( malignant hyperthermia )
- Weakness
- Feeling of illness
- A certain type of change (so-called ST-T change) in the heart is seen on an electrocardiogram ( ECG ). An EKG is an examination that is done to see and monitor how the heart’s electrical activity, which among other things controls the heart’s rhythm, works.
- A certain type of change (so-called T-wave inversion) in the heart is seen on an electrocardiogram ( ECG ). An EKG is an examination that is done to see and monitor how the heart’s electrical activity, which among other things controls the heart’s rhythm, works.
- Increased alanine aminotransferase (an enzyme mainly found in liver cells)
- Increased aspartate aminotransferase (an enzyme mainly found in liver and heart cells)
- Increased level of bilirubin in the blood
- Abnormal blood coagulation test result
- Ammonium increase
- Irritation after completed surgery
How to store Suprane
Keep this medicine out of the sight and reach of children.
Use before the expiry date stated on the label after Ex. dat. The expiration date is the last day of the specified month.
Suprane should be stored upright with the lid tightly closed.
Contents of the packaging and other information
Contents declaration
The active substance is desflurane. The medicine consists only of the active substances.
Appearance and package sizes of the medicine
Suprane is supplied in a glass bottle (made of brown glass type III with a protective coating of PVC plastic) or an aluminum bottle (made of aluminum coated with an inner protective varnish of epoxy phenolic resin) 240 ml or 6 x 240 ml respectively. Both the glass and aluminum bottles are fitted with a valve cap compatible with the special carburetor.
Marketing Authorisation Holder
Baxter Medical AB
Box 63
164 94 Coffin
Manufacturer
Baxter SA
Lessin’s
Belgium