100% inhalation vapor, liquid
What Sevoflurane Baxter is and what it is used for
Sevoflurane Baxter contains sevoflurane. Sevoflurane is an anesthetic used in surgery on children and adults. It is an anesthetic for inhalation (it is given as a vapor you inhale). By inhaling sevoflurane vapor, you sleep deeply and feel no pain. It also maintains deep, painless sleep (anesthesia) so that you can undergo surgery.
You need to talk to a doctor if you do not feel better or if you feel worse.
What you need to know before you receive Sevoflurane Baxter
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Sevoflurane should only be given by healthcare professionals who are trained in general anesthesia and under the supervision of an anesthetist.
Your anesthetist will not give you Sevoflurane Baxter:
- if you are allergic (hypersensitive) to sevoflurane vapor or other inhalation anesthetics.
- if you have previously had confirmed hepatitis ( hepatitis ) caused by sevoflurane or other inhalation anesthetics, or if you have previously had unexplained liver problems with jaundice, fever, and elevated levels of a certain type of white blood cell.
- if you have a known or suspected tendency to have malignant hyperthermia (a sudden and dangerous increase in body temperature during or shortly after a surgical procedure).
- if there are medical reasons why you should not be given a medicine for general anesthesia
If any of the above apply to you, tell your anesthetist before taking this medicine.
Warnings and cautions
Talk to your doctor or pharmacist before taking Sevoflurane Baxter:
- if you have been given an inhaled anesthetic before, especially if it was given repeatedly over a short period
- if you have low blood pressure
- if you have a decrease in blood volume or are weakened
- if you have impaired kidney function
- if you are pregnant or breast-feeding or if you are taking this medicine at the time of delivery (see also section Pregnancy and breast-feeding)
- if you suffer from coronary heart disease (a disease of the blood vessels that supply your heart with blood)
- if you are at risk of high blood pressure
- if you have or have previously had liver problems such as hepatitis (hepatitis) or jaundice.
- if you are being treated with a medicine that can cause liver problems
- if you have a known risk of having seizures
- 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 that case, your anesthesiologist will stop giving sevoflurane and to treat the malignant hyperthermia you will be given a medicine called dantrolene as well as other supportive treatment. Fatal malignant hyperthermia has been reported with sevoflurane.
- if you have a neuromuscular disease (for example Duchenne muscular dystrophy)
- if you have a cell disease (a condition called mitochondrial disease)
Children
- if you have Down syndrome
If any of the above apply to you, talk to your doctor, nurse, or pharmacist. You may need careful checks and the treatment may change.
Other medicines and Sevoflurane Baxter
Tell your doctor, pharmacist, surgeon, or anesthetist if you are taking, have recently taken, or might take any other medicines. This also applies to herbal medicines, vitamins, and minerals.
The medicines or active substances contained in the medicines, listed below may affect each other’s effects when used together with Sevoflurane Baxter. Some of these medicines are given to you by your anesthetist during the surgical procedure, as stated in the description.
- Nitric oxide (nitrous oxide): This is a drug used in general anesthesia which induces sleep and relieves pain.
- Opioids (eg morphine, fentanyl, remifentanil): These medicines are very painkillers and are often used under general anesthesia.
- Non-depolarizing muscle relaxants (eg pancuronium, atracurium): These medicines are used under general anesthesia to relax your muscles.
- Benzodiazepines (eg diazepam, lorazepam): These are sedatives, which relieve anxiety. They are used if, for example, you feel anxious before the operation.
- Adrenaline: This drug is often used to treat allergic reactions, but can also be used in general anesthesia.
- Verapamil: This is a heart medicine and is given as a treatment for high blood pressure or irregular heartbeat.
- Beta-blockers (eg atenolol, propranolol): These are heart medications that are often given as a treatment for high blood pressure.
- Indirect sympathomimetic drugs, such as amphetamines (used to treat ADHD (Attention Deficit Hyperactivity Disorder) or narcolepsy ) or ephedrine (mucosal decongestants that may be present in cough medicines).
- Isoniazid: A drug used to treat tuberculosis (TB)
- Alcohol
- St. John’s wort: this is a herbal remedy used for depression.
Sevoflurane Baxter with food and drink:
Sevoflurane Baxter is a medicine that puts you to sleep and keeps you asleep so that you can undergo surgery. Consult your doctor, surgeon, or anesthetist about when and what you can eat or drink after waking up.
Pregnancy, breastfeeding, and fertility
If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor, surgeon or anesthetist before taking this medicine.
Driving and using machines
Sevoflurane Baxter has a profound effect on your ability to drive and use tools or machines. Do not drive or use any tools or machines until your doctor tells you it is safe. Anesthetics can affect wakefulness for several days. This can affect your ability to perform tasks that require sharp attention.
Consult your anesthetist when it is safe for you to drive and use machines again.
How to get Sevoflurane Baxter
Sevoflurane Baxter is given to you by an anesthetist. The anesthesiologist will decide how many doses you need and when to get them.
Dose one varies depending on your age, weight, the type of surgery you are going to undergo, and what other medications you will receive during the operation.
Sevoflurane Baxter is made from liquid sevoflurane using a carburetor specially designed for use with sevoflurane. You may be asked to inhale sevoflurane gas through a mask to get you to sleep. You can also get an injection of another anesthetic that makes you fall asleep before you get sevoflurane through a mask or via a so-called throat tube.
The anesthetist will decide when it’s time to stop giving you Sevoflurane Baxter. You will then wake up after a few minutes.
If you take more Sevoflurane Baxter than you should
Sevoflurane Baxter will be given by healthcare professionals and it is unlikely that you will receive too much Sevoflurane Baxter. If you get too much Sevoflurane Baxter, your anesthetist will take the necessary steps.
Possible side effects
Like all medicines, Sevoflurane Baxter can cause side effects, although not everybody gets them.
Most side effects are mild to moderate in severity and short-lived, but there are also serious side effects.
Serious side effects ( may be life-threatening)
- Acute allergic reactions such as anaphylaxis and anaphylactoid reactions (see side effects section no known frequency for more information).
If these symptoms occur while you are being given Sevoflurane Baxter, your anesthetist will take the necessary action.
Very common side effects (affects more than 1 user in 10)
- agitation (restlessness and anxiety).
- slow pulse
- low blood pressure
- cough
- nausea and vomiting
Common side effects (affects 1 to 10 users in 100)
- drowsiness or a feeling of being very tired
- headache
- dizziness
- fast pulse
- high blood pressure
- respiratory disorders
- airway narrowing
- slow and shallow breathing
- cramp in the throat
- increased salivation
- fever
- overindulge
- elevated or decreased levels of white blood cells. It May affect the immune system and, among other things, cause increased susceptibility to infection
- elevated levels of glucose (sugar) in the blood, detected by blood tests
- elevated liver enzymes, detected by blood tests
- elevated levels of fluoride in the blood, detected using blood tests
- lowered body temperature
Uncommon side effects (affects 1 to 10 users in 1000)
- confusion
- palpitations or irregular heartbeats
- AV block (a disease that affects the conduction system of the heart)
- apnea (respiratory arrest)
- asthma
- hypoxia (low blood oxygen level)
- elevated levels of serum creatinine (indication of renal impairment), detected by blood tests
No known frequency (frequency can not be calculated from available data)
- allergic reactions, for example:
- rash
- redness of the skin
- urticaria (hives)
- itching
- swelling of the eyelids
- breathing difficulties
- anaphylaxis and anaphylactoid reactions. These allergic reactions occur suddenly and can be life-threatening. Symptoms of anaphylaxis include:
- angioedema (swelling of the skin of the face, body parts, lips, tongue, or throat)
- breathing difficulties
- low blood pressure
- urticaria (hives)
- epilepsy-like seizures
- sudden twitches
- cardiac arrest
- respiratory cramps
- difficulty breathing or wheezing
- tendency to hold one’s breath
- shortness of breath
- hepatic impairment or hepatitis (inflammation of the liver), symptoms of which are decreased appetite, fever, nausea, vomiting, abdominal discomfort, jaundice, and dark-colored urine
- dangerously high body temperature
- chest discomfort
- increased pressure in the skull
- irregular heartbeat or palpitations
- inflammation of the pancreas
- elevated levels of potassium in the blood, as seen in blood tests
- muscle stiffness
- the skin looks yellow
- inflammation of the kidneys (symptoms may include fever, confusion or drowsiness, rash, swelling, more or less urine than normal, and blood in the urine)
- swelling
Sometimes seizures occur. It can occur when you receive Sevoflurane Baxter, or up to one day later during recovery. It usually affects children and young adults. When children with Down syndrome get sevoflurane, a decrease in heart rate may occur.
Blood fluoride levels may rise slightly during and immediately after anesthesia, but these levels are not thought to be harmful and will soon return to normal.
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. Some side effects may need to be treated.
How to store Sevoflurane Baxter
Keep out of sight and reach of children.
Use Sevoflurane Baxter before the expiry date which is stated on the label. The expiration date is the last day of the specified month.
This medicine has no special storage instructions.
Contents of the packaging and other information
Content declaration
The active substance is sevoflurane 100% (250 ml in a 250 ml bottle).
The drug consists only of active substances.
What the medicine looks like and the contents of the pack
Sevoflurane is a clear, colorless inhalation vapor, and liquid.
It is delivered in aluminum bottles of 250 ml with an inner protective lid.
The bottle can be sealed with
- a plastic screw cap or
- an integrated valve that is connected directly to a suitable carburetor.
Pack sizes: 1 and 6 bottles.
Eventually, all pack sizes will be marketed.
Marketing Authorization Holder and Manufacturer
Baxter Medical AB
Box 63
164 94 Kista
Manufacturer:
Baxter SA
Boulevard Rene Branquart 80,
B-7860 Lessines,
Belgium
Further information on this medicine can be obtained from the representative of the marketing authorization holder.
Baxter is a trademark of Baxter International Inc.