Sevoflurane Baxter

Package leaflet: Information for the user

Sevoflurane Baxter 100% Inhalation Liquid

Active substance: sevoflurane
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, consult your doctor or pharmacist.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. See section 4.

What this leaflet contains:

1. What Sevoflurane Baxter is and what it is used for
2. What you need to know before you are given Sevoflurane Baxter
3. How Sevoflurane Baxter will be administered to you
4. Possible side effects
5. How to store Sevoflurane Baxter
6. Contents of the pack and other information

1. WHAT SEVOFLURANE BAXTER IS AND WHAT IT IS USED FOR

Sevoflurane Baxter contains sevoflurane. Sevoflurane is a general anaesthetic used in surgery for adults and children. It is an inhaled anaesthetic (administered as a vapour to be breathed in). Inhaling sevoflurane vapour induces deep sleep without pain sensation. It also maintains a state of deep sleep without pain perception (general anaesthesia) during surgical procedures.
Speak to your doctor if you do not feel better or if you feel worse.

2. WHAT YOU NEED TO KNOW BEFORE TAKING SEVOFLURANE BAXTER

Sevoflurane must be administered only by appropriately trained medical personnel in the administration of general anesthesia, under the supervision of an anesthetist or directly by an anesthetist.
Your anesthetist (doctor) will not administer Sevoflurane Baxter to you if:

• You are allergic (hypersensitive) to sevoflurane or to other inhaled anesthetics
• You have a confirmed history of liver inflammation (hepatitis) due to sevoflurane or other inhaled anesthetics, or if you have a history of unexplained liver problems accompanied by jaundice, fever, and an increased number of a certain type of white blood cells
• You have a known or suspected susceptibility to malignant hyperthermia (a sudden and dangerously high increase in body temperature during or immediately after surgery)
• There are medical reasons why a general anesthetic should not be administered to you

If any of the above conditions apply, inform your anesthetist (doctor) before this medicine is administered.
Warnings and Precautions:
Talk to your doctor or pharmacist before taking Sevoflurane Baxter if:

• You have previously been given an inhaled anesthetic, especially if more than once in a short period of time (repeated use)
• Your blood pressure is low
• You are hypovolemic (reduced blood volume) or weak
• You have reduced kidney function
• You are pregnant or breastfeeding, or when this medicine is used in obstetric anesthesia (childbirth) (see also the section titled “Pregnancy and breastfeeding”)
• You have coronary disease
• You are at risk of increased pressure in the brain
• You have or have previously had liver problems, for example hepatitis (liver inflammation) or jaundice
• You are taking medicines that may cause liver problems
• You have or are at risk of seizures
• In the rare and unexpected event that you develop malignant hyperthermia (a sudden and dangerously high increase in body temperature during or immediately after surgery). In this case, your anesthetist (doctor) will stop administration of sevoflurane and you will be given a medicine to treat malignant hyperthermia (known as dantrolene) and receive additional supportive therapy. Fatal outcomes of malignant hyperthermia have been reported with sevoflurane.
• You have a neuromuscular disease such as Duchenne muscular dystrophy
• You have a cellular disorder (a condition called mitochondrial dysfunction)

Children

• If you have Down syndrome

If any of the above conditions apply, consult your doctor, nurse, or pharmacist. You may require careful evaluation and your treatment may need to be modified.
Sevoflurane and other medicines:
Inform your doctor, pharmacist, surgeon, or anesthetist if you are taking, have recently taken, or might take any other medicines. This also includes herbal products, vitamins, and minerals.
The medicines or active substances listed below may interact with each other when used together with Sevoflurane Baxter. Some of these medicines are administered by the anesthetist during surgery as indicated in the description.

• Nitrous oxide: This is a medicine used during general anesthesia to induce sleep and relieve pain.
• Opioids (e.g., morphine, fentanyl, remifentanil): These are strong painkillers often used during general anesthesia.
• Non-depolarizing muscle relaxants (e.g., pancuronium, atracurium): These medicines are used during general anesthesia to relax muscles.
• Benzodiazepines (e.g., diazepam, lorazepam): These are sedative medicines that have a calming effect. They are used when the patient is agitated, for example before surgery.
• Adrenaline: This is a medicine often used to treat allergic reactions, but it may also be used during general anesthesia.
• Verapamil: This is a heart medicine used to treat high blood pressure or irregular heartbeat.
• Beta-blockers (e.g., atenolol, propranolol): These are heart medicines, often given to treat high blood pressure.
• Indirect sympathomimetic drugs, e.g., amphetamines (used to treat attention deficit hyperactivity disorder (ADHD) or narcolepsy) or ephedrine (used as a decongestant and commonly found in cough and cold medicines)
• Isoniazid: A medicine used to treat tuberculosis (TB)
• Alcohol
• St. John’s Wort: a herbal remedy used for depression

Sevoflurane Baxter with food and drink
Sevoflurane Baxter is a medicine that induces and maintains sleep to allow surgery. Ask your doctor, surgeon, or anesthetist when and what you can eat or drink after waking up.
Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant, or if you are planning to have a baby, ask your doctor, surgeon, or anesthetist for advice before this medicine is administered to you.
Driving and using machines
Sevoflurane Baxter significantly impairs your ability to drive and use machinery. Do not drive or operate tools or machinery until your doctor tells you it is safe. Administration of an anesthetic may impair alertness for several days. This may affect your ability to perform activities requiring mental alertness.
Consult your anesthetist to find out when it will be safe for you to drive and use machinery again.

3. HOW SEVOFLURANE BAXTER WILL BE ADMINISTERED TO YOU

Sevoflurane Baxter will be administered to you by an anaesthetist. The anaesthetist will decide the dose you require and when it should be given. The dose will vary depending on your age, weight, type of surgical procedure, and other medications you may receive during surgery.
Sevoflurane Baxter is produced from liquid sevoflurane using a vaporizer specifically designed for use with sevoflurane. You may be asked to inhale the sevoflurane vapour through a mask to induce sleep. Alternatively, you may also be given an injection of another anaesthetic to put you to sleep before Sevoflurane Baxter is administered via a mask or a tube inserted into your throat.
Your anaesthetist will decide when to stop administering Sevoflurane Baxter. You will wake up within a few minutes.
If you are given more Sevoflurane Baxter than you should
Sevoflurane Baxter will be administered by a healthcare professional, so it is unlikely that you will receive too much. However, if you are given an excessive dose of Sevoflurane Baxter, your anaesthetist will take the necessary measures.

4. POSSIBLE ADVERSE REACTIONS

Like all medicines, this drug can cause adverse reactions, although not everyone experiences them.
Most adverse reactions are mild to moderate in severity and short-lived; however, serious adverse reactions may also occur.

Serious adverse reactions (potentially life-threatening)

• Anaphylactic and anaphylactoid reactions (for further information, see the section on adverse reactions not known).

If these symptoms occur during administration of Sevoflurane Baxter, the anaesthesiologist will take the most appropriate action.

Very common adverse reactions (affect more than 1 in 10 users)

• Agitation (restlessness and psychological discomfort)
• Slow heart rate
• Low blood pressure
• Cough
• Nausea (feeling unwell) and vomiting (state of malaise)

Common adverse reactions (affect 1 to 10 in 100 users)

• Drowsiness or feeling very sleepy
• Headache
• Dizziness
• Fast heart rate
• High blood pressure
• Breathing problems
• Airway obstruction
• Slow and weak breathing
• Laryngospasm
• Increased salivation
• Fever
• Chills
• Increase or decrease in white blood cell count, which may affect the immune system, for example increased susceptibility to infections
• Increased blood glucose (sugar) levels, as detected by a blood test
• Increased liver enzymes, as detected by a blood test
• Increased blood fluoride levels, as detected by a blood test
• Decreased body temperature

Uncommon adverse reactions (affect 1 to 10 in 1,000 users)

• Confusion
• Palpitations or irregular heartbeat
• Atrioventricular block (a disorder of the heart's electrical conduction)
• Apnea (cessation of breathing)
• Asthma
• Hypoxia (low oxygen levels in the blood)
• Increased creatinine levels in the blood (an indicator of reduced kidney function), as detected by a blood test

Not known (frequency cannot be estimated from available data)

• Allergic reactions, for example:
• Skin rashes
• Skin redness
• Urticaria (hives)
• Itching
• Swollen eyelids
• Breathing difficulties
• Anaphylaxis and anaphylactoid reactions. These allergic reactions occur rapidly and can be life-threatening. Symptoms of anaphylaxis include:
• Angioedema (swelling of the skin of the face, limbs, lips, tongue or throat)
• Breathing difficulties
• Low blood pressure
• Urticaria (hives)
• Confused mental state
• Seizure-like episodes
• Sudden muscle contractions
• Cardiac arrest
• Airway spasms
• Difficulty breathing or wheezing
• Breath holding
• Shortness of breath
• Reduced liver function or hepatitis (liver inflammation), characterized for example by loss of appetite, fever, nausea, vomiting, abdominal discomfort, jaundice and dark urine.
• Dangerous increase in body temperature
• Chest discomfort
• Increased intracranial pressure
• Irregular heartbeat or palpitations
• Pancreatitis (inflammation of the pancreas)
• Increased blood potassium levels, as revealed by a blood test
• Muscle rigidity
• Yellowing of the skin
• Kidney inflammation (symptoms may include fever, confusion or drowsiness, skin rash, swelling, increased or decreased urine output, and blood in the urine)
• Swelling

Seizures sometimes occur. These may happen during administration of Sevoflurane Baxter, or up to one day afterwards during recovery. They occur mainly in children and young adults.

In children with Down's syndrome receiving sevoflurane, a slowing of heart rate may occur.

Blood fluoride levels may rise slightly during and immediately after anaesthesia, but these levels should not be considered harmful and return to normal quickly.

If any of the adverse reactions worsen, or if you notice any adverse reaction not listed in this leaflet, inform your doctor or pharmacist.

If you notice changes in how you feel after receiving sevoflurane, inform your doctor or pharmacist. Some adverse reactions may require treatment.

Reporting of adverse reactions
If you experience any adverse reaction, including those not listed in this leaflet, please contact your doctor, pharmacist or nurse.

You can also report adverse reactions directly via the national reporting system at the following website: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.

By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. HOW TO STORE SEVOFLURANE BAXTER

Keep this medicine out of the sight and reach of children.
Do not use Sevoflurane Baxter after the expiry date stated on the label. The expiry date refers to the last day of the month.
This medicine does not require any special storage conditions.

6. Package contents and other information

What Sevoflurane Baxter contains
The active substance is sevoflurane 100% (250 ml in a 250 ml bottle).
There are no excipients.
Description of the appearance of Sevoflurane Baxter and contents of the pack
Sevoflurane is a clear, colourless liquid for inhalation.
It is supplied in 250 ml aluminium bottles with a protective lining.
The bottle may be closed with

• a plastic screw cap.
• an integrated valve designed for direct connection to a suitable vaporizer.

Packs of 1 and 6 bottles.
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Baxter S.p.A.
Via del Serafico 89
00142 Rome
Italy
Released by
Baxter SA,
Boulevard Rene Branquart 80,
B-7860 Lessines,
Belgium
This medicinal product is authorised in the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

For further information about this medicinal product, please contact the local representative of the marketing authorization holder: