Sevoflurane baxter

Package leaflet: Information for the user

Sevoflurane Baxter, 100%, solution for inhalation vapour
Active substance: sevoflurane
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for the patient.

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

Contents of the leaflet

1. What Sevoflurane Baxter is and what it is used for
2. Important information before using Sevoflurane Baxter
3. How to use Sevoflurane Baxter
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 the active substance sevoflurane. Sevoflurane is an anaesthetic medicine used in surgery for adults and children. It is an inhaled anaesthetic (administered as a vapour to be breathed in). Breathing in sevoflurane vapour induces deep sleep, without pain sensation. It also maintains deep anaesthesia (general anaesthesia), during which a surgical procedure can be performed.
If there is no improvement or if the patient feels worse, please consult the doctor.

2. Important information before using Sevoflurane Baxter

Sevoflurane must be administered exclusively by qualified medical personnel
appropriately trained in the use of general anaesthesia, under the supervision of an anaesthetist or
by an anaesthetist.
The anaesthetist (physician) will not administer Sevoflurane Baxter to the patient if:

• there is hypersensitivity (allergy) to sevoflurane or any other inhalational anaesthetic agents;
• the patient has previously experienced a confirmed inflammatory liver condition (hepatitis) following administration of sevoflurane or other inhaled anaesthetics, or has unexplained liver disease with jaundice, fever, and elevated levels of one type of white blood cells;
• malignant hyperthermia (a sudden and dangerously high increase in body temperature during or shortly after surgery) is diagnosed or suspected;
• there are medical reasons contraindicating general anaesthesia.

If any of the above conditions apply, the anaesthetist (physician) must be informed before administering the drug.
Warnings and precautions
Before starting treatment with Sevoflurane Baxter, consult a physician or pharmacist if:

• the patient has previously received inhalational general anaesthetics, especially if administered more than once within a short period (repeated exposure);
• the patient has low blood pressure;
• the patient has hypovolemia (reduced blood volume) or is debilitated;
• the patient has impaired kidney function;
• the patient is pregnant or breastfeeding, or if this medicine is used during obstetric anaesthesia (childbirth) (see also section "Pregnancy, breastfeeding and fertility");
• the patient has ischemic heart disease;
• the patient is at risk of increased intracranial pressure;
• the patient has had or currently has liver disorders, such as hepatitis or jaundice;
• the patient is being treated with a medicine that may cause liver problems;
• the patient has a history of, or is at risk for, seizures (epilepsy);
• in rare and unpredictable cases, the patient develops malignant hyperthermia (a sudden and dangerously high increase in body temperature during or shortly after surgery). In such cases, the anaesthetist (physician) will discontinue sevoflurane administration and administer dantrolene to treat malignant hyperthermia, along with supportive therapy. Fatal cases of malignant hyperthermia have been reported during sevoflurane use;
• the patient has a neuromuscular disorder, such as Duchenne muscular dystrophy;
• the patient has a cellular disorder (a condition known as mitochondrial disorder).

Children

• in children with Down syndrome

If any of the above conditions apply, confirmation should be obtained from a physician,
nurse, or pharmacist. The patient may require thorough evaluation, and treatment may
need to be modified.
Other medicines and Sevoflurane Baxter
Inform the physician, pharmacist, surgeon, or anaesthetist about all medicines currently used,
recently used, or planned for use. This includes herbal remedies, vitamins, and minerals.
The following medicines or active substances may interact with Sevoflurane Baxter when used concomitantly. Some of these medicines are administered during surgery by the anaesthetist as described.

• Nitrous oxide: an agent used during general anaesthesia to induce unconsciousness and relieve pain;
• Opioids (e.g. morphine, fentanyl, remifentanil): potent analgesics, frequently used during general anaesthesia;
• Non-depolarizing muscle relaxants (e.g. pancuronium, atracurium): medicines used during general anaesthesia to relax muscles;
• Benzodiazepines (e.g. diazepam, lorazepam): sedatives with calming effects, used for anxiety, for example before surgery;
• Epinephrine: a medicine commonly used to treat allergic reactions, but may also be used during general anaesthesia;
• Verapamil: a cardiac medicine used in the treatment of hypertension or cardiac arrhythmias;
• Beta-blockers (e.g. atenolol, propranolol): cardiac medicines frequently used in the treatment of hypertension;
• Indirect-acting sympathomimetic agents, e.g. amphetamines (used in the treatment of attention deficit hyperactivity disorder (ADHD) or narcolepsy) or ephedrine (used as a vasoconstrictor and commonly found in cough and cold medicines);
• Isoniazid: a medicine used in the treatment of tuberculosis (TB);
• Alcohol;
• St. John's wort: a herbal preparation used for depression.

Sevoflurane Baxter with food and drink
Sevoflurane Baxter is a medicine that induces and maintains anaesthesia to allow surgical procedures. Ask the physician, surgeon, or anaesthetist when and what the patient may eat or drink after recovery from anaesthesia.
Pregnancy, breastfeeding and fertility
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning pregnancy,
she should consult a physician, surgeon, or anaesthetist before using this medicine.
Driving and operating machinery
Sevoflurane Baxter has a very strong effect on the ability to drive and use tools.
Driving, using tools, or operating any mechanical equipment must be avoided until the physician considers it safe. Anaesthetic agents may impair patient perception for several days. They may also affect the ability to perform intellectual tasks.
Ask the anaesthetist when the patient can safely resume driving and operating mechanical devices.

3. How to use Sevoflurane Baxter

Sevoflurane Baxter will be administered by an anaesthetist. The anaesthetist will determine the appropriate dose and duration of administration for the patient. The dose will vary depending on age, body weight, the type of surgical procedure required, and other medications administered during surgery.
Sevoflurane Baxter is produced from liquid sevoflurane using a device called a vaporizer, specifically designed for use with sevoflurane. Induction of anaesthesia may be carried out by inhalation of sevoflurane vapour through a mask. The patient may also receive an injection of another anaesthetic drug to induce unconsciousness before administration of Sevoflurane Baxter via a mask or endotracheal tube.
The anaesthetist will decide when to discontinue administration of Sevoflurane Baxter. Recovery from anaesthesia usually occurs within a few minutes.
Overdose of Sevoflurane Baxter
Sevoflurane Baxter will be administered by qualified medical personnel, and it is unlikely that a patient would receive too much Sevoflurane Baxter. In the event that an excessive dose of Sevoflurane Baxter is administered, the anaesthetist will take all necessary measures.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
Most adverse reactions are mild to moderate in intensity and short in duration, but severe adverse reactions may also occur.
Severe adverse reactions (may be life-threatening)

• anaphylaxis and pseudoallergic reactions (see Adverse reactions of unknown frequency for additional information).

If these symptoms occur while administering Sevoflurane Baxter to a patient, the anaesthesiologist will take appropriate action.
Very common adverse reactions (affects more than 1 in 10 patients)

• excitation (agitation and restlessness)
• bradycardia (slow heart rate)
• decreased blood pressure
• coughing
• nausea and vomiting

Common adverse reactions (affects 1 to 10 in 100 patients)

• drowsiness or feeling sleepy
• headache
• dizziness
• tachycardia (rapid heartbeat)
• high blood pressure
• breathing disorders
• airway obstruction
• slow and shallow breathing
• throat spasms
• increased salivation
• fever
• chills
• increased or decreased white blood cell count, which may affect the immune system, i.e. increased susceptibility to infections
• elevated blood glucose (sugar) levels, detected in a blood sample test
• increased liver enzyme activity, detected in a blood sample test
• elevated fluoride concentration in blood, detected in a blood sample test
• decreased body temperature

Uncommon adverse reactions (affects 1 to 10 in 1,000 patients)

• confusion
• palpitations or irregular heartbeat
• atrioventricular block (a disturbance in the conduction of electrical impulses in the heart)
• apnoea (cessation of breathing)
• asthma
• hypoxia (reduced oxygen levels in the blood)
• elevated blood creatinine levels (an indicator of impaired kidney function), detected in a blood sample test

Adverse reactions of unknown frequency (frequency cannot be estimated from available data)

• allergic reactions, including:
• rash
• skin redness
• urticaria
• itching
• eyelid swelling
• breathing difficulties
• anaphylaxis and pseudoallergic reactions. These allergic reactions occur rapidly and may be life-threatening. Symptoms of anaphylactic reaction include:
• angioedema (swelling of the face, limbs, lips, tongue or throat)
• breathing difficulties
• low blood pressure
• urticaria
• disturbances of consciousness
• epileptic-like seizures
• muscle twitching
• cardiac arrest
• bronchospasm
• breathing difficulties or wheezing
• respiratory arrest
• dyspnoea
• liver dysfunction or hepatitis, characterised by, among others, loss of appetite, fever, nausea, vomiting, abdominal pain, jaundice and dark urine
• dangerous increase in body temperature
• feeling of discomfort in the chest
• increased intracranial pressure
• irregular heartbeat or palpitations
• pancreatitis
• increased potassium levels in blood, detected in a blood sample test
• muscle rigidity
• yellowing of the skin
• kidney inflammation (symptoms may include fever, disorientation or drowsiness, rash, swelling, production of less or more urine than usual, and blood in urine)
• oedema

Seizures (attacks) have sometimes been observed. They may occur during administration of Sevoflurane Baxter or up to one day after anaesthesia. They occur mainly in children and young adults.
In children with Down's syndrome who receive sevoflurane, bradycardia (slowing of the heart rate) may occur.
During or immediately after anaesthesia, blood fluoride concentrations may be slightly elevated, but these are not considered harmful and return rapidly to normal.
If any of the adverse reactions worsen or if any adverse reactions not listed in this leaflet occur, inform your doctor or pharmacist.
If you notice any change in your condition after receiving sevoflurane, inform your doctor or pharmacist. Some adverse reactions may require treatment.
Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, tell your doctor, surgeon or nurse.
Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products
Al. Jerozolimskie 181C
02-222 Warsaw
Tel.: + 48 22 49 21 301
Fax: + 48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sevoflurane Baxter

The medicine should be stored 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 specified month.
No special storage instructions apply to this medicine.

6. Contents of the pack and other information

What Sevoflurane Baxter contains
The active substance is sevoflurane 100% (250 ml in a 250 ml bottle).
The product does not contain any other ingredients.

What Sevoflurane Baxter looks like and contents of the pack
Sevoflurane is a clear, colourless liquid for vaporization for inhalation.
It is supplied in aluminium bottles with a protective inner coating, with a capacity of 250 ml.
The bottle may be closed with:

• a plastic cap, or
• an integrated valve that connects directly to a suitable vaporizer.

Pack sizes: 1 or 6 bottles.
Not all pack types may be marketed.

Marketing Authorisation Holder and Manufacturer
MARKETING AUTHORISATION HOLDER
Baxter Polska Sp. z o.o.
ul. Kruczkowskiego 8
00-380 Warsaw
tel. 22 488 37 77

MANUFACTURER
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 names:

Baxter is a trademark of Baxter International Inc.