SEVOFLURANE 250 ML Inhalation solution

Зміст інструкції

1. Sevoflurane Baxter 100% Liquid for inhalation
   1. WHAT IS SEVOFLURANE BAXTER AND WHAT IS IT USED FOR
   2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE 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

Sevoflurane Baxter 100% Liquid for inhalation

Active ingredient: sevoflurane

Read this leaflet carefully before using this medicine as it contains important
information for you.

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

What is in this leaflet:

• 1. What Sevoflurane Baxter is and what it is used for
• 2. What you need to know before Sevoflurane Baxter is administered to you
• 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 IS SEVOFLURANE BAXTER AND WHAT IS IT USED FOR

Sevoflurane Baxter contains sevoflurane. Sevoflurane is a general anesthetic used in surgery
for adults and children. It is an inhalation anesthetic, (it is administered in the form of vapor to
inhale). Inhalation of sevoflurane vapor induces a deep sleep without perception of pain.
It also maintains a condition of deep sleep without perception of pain (general anesthesia)
during the performance of the surgical intervention.
Contact your doctor if you do not feel better or if you feel worse.

2. WHAT YOU NEED TO KNOW BEFORE YOU RECEIVE SEVOFLURANE BAXTER

Sevoflurane must only be administered by appropriately trained medical personnel in the
administration of general anesthesia under the supervision of an anesthesiologist or directly by an
anesthesiologist.

Your anesthesiologist (doctor) will not administer Sevoflurane Baxter to you if:

• You are allergic (hypersensitive) to sevoflurane or other inhalation anesthetics
• You have a confirmed history of inflamed liver (hepatitis) due to sevoflurane or other inhalation 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 to you, inform your anesthesiologist (doctor) before
this medicine is administered to you.

Warnings and Precautions:
Consult your doctor or pharmacist before taking Sevoflurane Baxter if:

• You have previously been administered an inhalation 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 administered in obstetric anesthesia (childbirth) (see also the section entitled “Pregnancy and breastfeeding”)
• You have coronary artery 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 can cause liver problems
• You suffer from 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 anesthesiologist (doctor) will stop the administration of sevoflurane and you will be given a medicine to treat malignant hyperthermia (known as dantrolene) and will receive other supportive therapy. Fatal outcomes of malignant hyperthermia have been reported with sevoflurane.
• If you have a neuromuscular disease such as, for example, Duchenne muscular dystrophy.
• If you have a cellular alteration (a condition called mitochondrial dysfunction)

Children

• If you have Down's syndrome

If any of the above conditions apply to you, consult your doctor, nurse or
pharmacist. You may need careful examination and treatment may be modified.

Sevoflurane and other medicines:
Tell your doctor, pharmacist, surgeon or anesthesiologist if you are taking, have recently taken or
may take any other medicines. This also applies to herbal products, vitamins and
minerals.
The medicines or active ingredients contained in the medicines listed below may interact with each other if
used together with Sevoflurane Baxter. Some of these medicines are administered by the anesthesiologist
during surgery as indicated in the description.

• Nitrous oxide: This is a medicine used during general anesthesia that induces sleep and relieves 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 for muscle relaxation.
• Benzodiazepines (e.g. diazepam, lorazepam): These are sedative drugs 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 can also be used during general anesthesia.
• Verapamil: This is a medicine for the heart and is administered to treat high blood pressure or an irregular heartbeat.
• Beta-blockers (e.g. atenolol, propranolol): These are medicines for the heart, often administered 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 for the treatment of tuberculosis (TB)
• Alcohol
• St John's Wort: is a herbal remedy used for depression

Sevoflurane Baxter with food and drink
Sevoflurane Baxter is a medicine that induces and maintains sleep to allow the
surgical intervention. Ask your doctor, surgeon or anesthesiologist when and what you can eat or drink after
awakening.

Pregnancy, breastfeeding and fertility
If you are pregnant or breastfeeding, if you think you may be pregnant or are planning
to become pregnant, ask your doctor, surgeon or anesthesiologist for advice before this medicine is
administered to you.

Driving and using machines
Sevoflurane Baxter severely affects your ability to drive and use tools. Do not
drive or use tools or machinery until your doctor tells you it is safe. The administration
of an anesthetic can impair the state of alertness for several days. This may affect your
ability to perform activities that require mental alertness.
Consult your anesthesiologist 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 anesthesiologist. The anesthesiologist will decide what dose you need and when to administer it. The dose will vary depending on your age, your weight, the type of surgery and other medications that will be administered to you during the surgery.
Sevoflurane Baxter is produced from liquid sevoflurane by means of a vaporizer,
specifically designed for use with sevoflurane. You may be asked to inhale the vapor
of sevoflurane through a mask to induce sleep. You may also be given
an injection of another anesthetic to put you to sleep before Sevoflurane
Baxter is administered to you through a mask or a tube placed in your throat.
Your anesthesiologist will decide when to stop administering Sevoflurane Baxter. You will
wake up within a few minutes.

If you are given too much Sevoflurane Baxterthan you should
Sevoflurane Baxter will be administered to you by a healthcare professional and it is unlikely that you will receive
too much Sevoflurane Baxter. If you are given an excessive dose of Sevoflurane Baxter, your
anesthesiologist will take the necessary measures.

4. POSSIBLE SIDE EFFECTS

Like all medicines, this medicine can cause side effects, although not everyone gets them.
Most side effects are mild to moderate in severity and of short duration; however, serious side effects can also occur.

Serious side effects(potentially life-threatening)

• anaphylactic and anaphylactoid reactions (for further information, see the section on unrecognised side effects).

If these symptoms occur during the administration of Sevoflurane Baxter, the anaesthetist will intervene
in the most appropriate way.

Very common side effects(affect more than 1 in 10 people)

• agitation (restlessness and mental discomfort).
• slowed heartbeat
• low blood pressure
• cough
• nausea (feeling unwell) and vomiting (feeling sick)

Common side effects (affect 1 to 10 users in 100)

• drowsiness or feeling very sleepy
• headache
• dizziness
• fast heartbeat
• high blood pressure
• breathing problems
• obstruction of the airways
• slow and weak breathing
• laryngospasm
• increased salivation
• fever
• chills
• increased or decreased number of white blood cells which can affect the immune system, for example an increased susceptibility to infections
• increased glucose (sugar) level in the blood, as detected by a blood test
• increases in liver enzymes, as detected by a blood test
• increased fluoride level in the blood, as detected by a blood test
• reduction of body temperature

Uncommon side effects (affect 1 to 10 users in 1000)

• confusion
• palpitations or irregular heartbeat
• atrioventricular block (a disturbance of the heart's electrical conduction)
• apnea (cessation of breathing)
• asthma
• hypoxia (low level of oxygen in the blood)
• increased levels of creatinine 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, e.g.:
• skin rashes
• skin redness
• urticaria (hives)
• itching
• swollen eyelids
• difficulty breathing
• 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)
• difficulty breathing
• low blood pressure
• urticaria (hives)
• confused mental state
• seizure-like attacks
• sudden muscle contractions
• cardiac arrest
• spasms of the airways
• difficulty breathing or wheezing
• breath-holding
• shortness of breath
• reduced liver function or hepatitis (inflammation of the liver), characterised for example by loss of appetite, fever, nausea, vomiting, abdominal discomfort, jaundice and dark urine
• dangerous increase in body temperature
• chest discomfort
• an increase in pressure in the skull
• irregular heartbeat or palpitations
• inflammation of the pancreas
• increased levels of potassium in the blood as revealed by a blood test
• muscle stiffness
• yellowing of the skin
• inflammation of the kidneys (symptoms may include fever, confusion or drowsiness, rash, swelling, more or less urine than usual and blood in the urine)
• swelling

Sometimes seizures occur. These can happen when Sevoflurane Baxter is administered,
or up to a day later during recovery. They occur mainly in
children and young adults.
In children with Down's syndrome who are taking sevoflurane, a slowing of the
heart rate may occur.
Fluoride levels in the blood may rise slightly during and immediately after
anaesthesia, but these levels should not be considered harmful and soon return to normal.
If any of these side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor or pharmacist. Some side effects may require medical treatment.

Reporting of side effects
If you get any side effects, talk to your doctor, pharmacist or nurse. This includes any side effects not
listed in this leaflet. You can also report side effects directly through the national reporting system
at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
By reporting side effects 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. Contents of the pack and other information

What Sevoflurane Baxter contains
The active ingredient 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, colorless inhalation liquid.
It is supplied in 250 ml aluminum bottles with a protective coating.
The bottle can be closed with

• a plastic screw cap.
• an integrated valve used for direct connection to an appropriate 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

Released by
Baxter SA,
Boulevard Rene Branquart 80,
B-7860 Lessines,
Belgium
This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom
(Northern Ireland) under the following designations:

For further information on this medicine, contact the local representative of the Marketing Authorisation Holder: