100% Inhalation vapor, liquid
isoflurane
What Isoflurane Baxter is and what it is used for
Isoflurane Baxter contains isoflurane. Isoflurane Baxter is a general anesthetic drug used in surgery. It is an anesthetic for inhalation (it is given in the form of steam that you inhale). By inhaling isoflurane, you sleep deeply and feel no pain. Isoflurane Baxter also maintains a deep, painless sleep (general anesthesia) so that you can undergo surgery.
What you need to know before using Isofluran Baxter
Your doctor will NOT give you Isofluran Baxter:
- if you are allergic (hypersensitive) to isoflurane or other inhalation anesthetics .
- if you, or a relative of yours, suffer from a condition called malignant hyperthermia . Malignant hyperthermia is a sudden and dangerous increase in body temperature that develops during or shortly after a surgical procedure.
If any of the above apply to you, talk to your doctor, surgeon, or anesthetist before taking this medicine.
Warnings and cautions
Talk to your doctor, nurse, or pharmacist before taking Isofluran Baxter.
Your doctor will be extra careful when treating with this medicine if:
- you have a cell disease (a condition called mitochondrial disease).
- you have liver problems, such as:- hepatitis (hepatitis).- cirrhosis of the liver (a condition in which healthy liver tissue is replaced with scar tissue). This condition can occur if you drink too much alcohol.- any other liver disease.
- you have recently undergone surgery under general anesthesia.
- you suffer from or have an increased risk of QT prolongation (a change seen with ECG ), which makes you prone to developing irregular heartbeats.
- you have signs of illness that can not be linked to your operation e.g. severe headache, nausea, vomiting, severe chest pain or a condition affecting your muscles (a neuromuscular disease such as Duchenne muscular dystrophy or myasthenia gravis ).
- you have recently had an abortion.
- you suffer from bronchoconstriction (contraction of the lungs and airways, resulting in coughing, wheezing or shortness of breath).
- the patient is a child under 2 years.
Your anesthetist may give you a lower dose of Isofluran Baxter if:
- you have a low blood volume ( hypovolemia ).
- you have low blood pressure ( hypotension ).
- you are weakened.
Isoflurane Baxter can irritate the mucous membranes of the mouth and airways, which can increase saliva flow and increase the secretion of secretions from the trachea and upper respiratory tract. Especially in children, this can lead to breathing difficulties and muscle spasms in the larynx called laryngospasm.
If you are given Isofluran Baxter, you can get:
- changes in liver function and, in rare cases, severe liver damage.
- increased blood sugar levels (blood glucose values).
- decreased levels of a type of fat, called cholesterol , in your blood.
- altered levels of enzyme in your blood.
Isoflurane Baxter can cause malignant hyperthermia (a condition when you suddenly develop a dangerously high body temperature during or shortly after surgery). Deaths due to malignant hyperthermia have been reported with Isofluran Baxter.
Your doctor will monitor your breathing during treatment, especially if you are taking other medicines that may affect your breathing, such as:
- Sedatives (eg diazepam or nitrazepam).
- Strong painkillers (eg opioids such as fentanyl , morphine or remifentanil).
Isoflurane should only be given to you by specially trained healthcare professionals and with the help of a carburetor specifically designed for isoflurane.
There is a lack of experience in pregnant women and in obstetric surgery ( surgery in connection with childbirth), with the exception of caesarean section. Isoflurane should therefore be used with caution in these cases.
Other medicines and Isoflurane Baxter
Tell your doctor or nurse if you are taking, have recently taken, or might take any other medicines.
Your doctor will avoid giving you Isofluran Baxter if you are taking or taking any of the following medicines:
- Non-selective MAOIs ( monoamine oxidase inhibitors ). Your doctor will inform you to stop taking such medicines 15 days before your operation.
- Cardiac drugs called beta-sympathomimetics, e.g. isoprenaline and alpha- and beta-sympathomimetics (eg adrenaline and norepinephrine ). These drugs can cause a serious irregularity in your heartbeat.
Your doctor will be extra careful if you receive or take any of the following medicines:
- Beta blockers . These heart medications are usually given to treat high blood pressure .
- Isoniazid – a drug used to treat tuberculosis ( TB ).
- Indirect sympathomimetic drugs eg:- Amphetamines or amphetamine derivatives (used to treat hyperactivity disorder ( ADHD ).- Medicines that suppress your appetite.- Ephedrine and ephedrine derivatives. These drugs are commonly used in cough and cold medicines.
These medicines may increase the risk of high blood pressure if they are co-administered with Isofluran Baxter. Your doctor will tell you if and when you should stop taking these medicines.
- Muscle relaxants. These drugs are used under general anesthesia to relax your muscles. Your anesthetist may need to reduce the dose of one of these medicines.
- Opioid is. These strong painkillers are often used under general anesthesia .
- Calcium-blocking drugs. These drugs are used to treat high blood pressure .
- Sedatives, benzodiazepines.
Isoflurane Baxter with food, drink and alcohol
Isoflurane Baxter is a medicine that puts you to sleep and keeps you asleep, so you can have an operation. Ask your doctor, surgeon, or anesthesiologist when and what you can eat or drink when you wake up.
Pregnancy, breastfeeding and fertility
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 taking this medicine.
If you are pregnant, you will only receive Isofluran Baxter if the benefits outweigh the risks, as experience in treating pregnant women is limited. However, lower doses of isoflurane can be used for caesarean sections.
As it is unknown whether Isofluran Baxter is excreted in human milk, you should avoid breastfeeding after surgery, if you have received Isofluran Baxter.
Driving and using machines
Do not drive or use machines for at least 24 hours after your operation if you have received Isofluran Baxter. Being anesthetized can affect your alertness and behavior. This may affect your ability to perform normal tasks for up to 6 days. Make sure someone can accompany you home after the operation.
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. Descriptions of these effects and side effects can be found in other sections. Read all the information in this leaflet for guidance. If you are not sure, talk to your doctor or pharmacist.
3. How to get Isofluran Baxter
Isoflurane Baxter is ALWAYS given to you by an anesthetist. He or she will decide what dose you should receive. Dose one depends on your age, weight, and the type of surgery you are going to undergo.
Your child should be closely monitored when isoflurane is given.
Falling asleep at the start of anesthesia
Isoflurane is not recommended for insomnia in infants or children when anesthesia is started.
Medication before anesthesia
The anesthetist may give your child medication to prevent the effects on breathing and heart rate, which may occur when using isoflurane.
Isoflurane Baxter is produced from liquid isoflurane using a carburetor. You can get Isofluran Baxter in one of the following two ways:
- You may be given an injection of another anesthetic that will put you to sleep before you receive Isofluran Baxter through a mask. This is the most common way to get Isofluran Baxter.
- You may be asked to inhale isoflurane gas through a mask to make you fall asleep. You will then quickly fall asleep. This is a less common way to get Isoflurane Baxter.
After your surgery, your anesthesiologist will decide when it’s time to stop giving you Isoflurane Baxter. You will then wake up after a few minutes.
If you take more Isofluran Baxter than you should
If you take more Isofluran Baxter than you should, the supply will be stopped. You will get pure oxygen. Your blood pressure and heart function will be closely monitored as you recover.
If you have any further questions on the use of this product, ask your doctor, pharmacist, or nurse.
4. Possible side effects
Like all medicines, this medicine can cause side effects, although not everybody gets them. Most of the side effects are mild to moderate in severity as well as short-lived, but there can be serious side effects.
If you or your child experience unusual or unexpected symptoms after surgery, contact your doctor or anesthesiologist IMMEDIATELY.
The most common side effects are:
-Contraction of the muscles in the lungs and airways, which causes difficulty breathing.
-Increased levels of sugar or potassium in the blood.
-In connection with the use of inhalable anesthetics, there have been rare reports of abnormal heart rhythms (arrhythmias) and deaths in children shortly after surgery.
Has been reported (occurs in an unknown number of users):
Presence of carboxyhemoglobin in the blood
– Anaphylactic reaction (severe allergic reaction )
-Hypersensitivity
– Agitation (restlessness, restless and exaggerated movements), mood changes
-Confusion, seizures, impaired mental ability
-Regular heartbeats
-Unormal electrocardiogram ( ECG ), prolonged QT interval
-Increased, decreased, or irregular heartbeat (including ventricular tachycardia Torsade de Pointes )
Cardiac arrest
-Low blood pressure
-Bleeding
-Slow and shallow breathing
-Breathing, wheezing
-Muscle cramps in the larynx are called laryngospasm
-Facial swelling
– Contact dermatitis
-Rash
-Increased blood levels of a substance called creatinine
Decreased blood levels of a substance called urea
-Increased blood levels of a substance called creatine kinase
Intestinal twists (the muscles in your intestines may temporarily stop working, causing discomfort, swelling, and vomiting)
Nausea and vomiting
-The liver does not work properly, which can include liver damage and liver cell death
-Increased levels of a substance called bilirubin in the blood
-Shaking, chills
-Elevated body temperature caused by malignant hyperthermia
-Compression of discomfort in the chest
-Unormal levels of certain cells or substances in your blood
-Increased levels of fluoride in your blood (formed during the body’s breakdown of isoflurane)
-Unormal results in electroencephalogram ( EEC )
Presence of myoglobin (a substance that comes from the muscles) in the urine
-Muscle breakdown
Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist, or nurse. This also applies to any side effects not mentioned in this information. You can also report side effects directly to the Medical Products Agency. By reporting side effects, you can help increase drug safety information.
5. How to store Isofluran Baxter
Keep this medicine out of the sight and reach of children.
No special storage instructions
Do not use this medicine after the expiry date which is stated on the label after EXP. date. The expiration date is the last day of the specified month.
Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.
6. Contents of the packaging and other information
Content declaration
The active substance is isoflurane. The drug consists only of active substances.
What the medicine looks like and contents of the pack
Clear, colorless liquid.
Pack sizes:
1 x 100 ml
1 x 250 ml
6 x 250 ml
Not all pack sizes may be provided.
Marketing Authorization Holder and Manufacturer
Marketing Authorisation Holder:
Baxter Medical AB
Box 63
164 94 Kista
Manufacturer:
Baxter SA
Boulevard Rene Branquart 80
B-7860 Lessines
Belgium