Sevoflurane Baxter

Package Leaflet: Information for the User

Sevoflurane Baxter, 100%, Liquid for Inhalation Vapor

Active Substance: Sevoflurane

Please Read This Leaflet Carefully Before Using This Medicine, as It Contains Important Information for You.

Important Information for Patients.

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

Table of Contents of the Leaflet

• 1. What is Sevoflurane Baxter and What is it 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 Package 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 inhalational anesthetic (given by inhaling vapor) that induces deep sleep without feeling pain and maintains deep sleep without feeling pain (general anesthesia) during which surgery can be performed. If there is no improvement or the patient feels worse, they should consult a doctor.

2. Important Information Before Using Sevoflurane Baxter

Sevoflurane should only be administered by qualified medical personnel, properly trained in the administration of general anesthesia, under the supervision of an anesthesiologist or by an anesthesiologist.

The Anesthesiologist (Doctor) Will Not Administer Sevoflurane Baxter to the Patient:

• In case of hypersensitivity (allergy) to sevoflurane or any other inhalational anesthetics;
• In case the patient has had a confirmed inflammatory liver condition (hepatitis) due to the administration of sevoflurane or other inhalational anesthetics, or liver disease of unknown origin with jaundice, fever, and an increase in one type of white blood cell;
• In case of diagnosed or suspected susceptibility to malignant hyperthermia (sudden and dangerously high body temperature during or shortly after surgery).
• If there are medical reasons why general anesthesia cannot be performed.

If any of the above points apply, the anesthesiologist (doctor) should be informed before administering the medicine.

Warnings and Precautions

Before starting treatment with Sevoflurane Baxter, you should consult your doctor or pharmacist if:

• The patient has previously used inhalational general anesthetics, especially if it happened more than once in a short period (repeated use);
• The patient has low blood pressure;
• The patient has hypovolemia (reduced blood volume) or is weakened;
• The patient has kidney function disorders;
• The patient is pregnant or breastfeeding, or when this medicine is administered during obstetric anesthesia (childbirth) (see also section "Pregnancy, Breastfeeding, and Fertility");
• The patient has coronary heart disease;
• The patient has an increased risk of elevated intracranial pressure;
• The patient has had liver disease, such as hepatitis or jaundice;
• The patient is undergoing treatment with a drug that may cause liver problems;
• The patient has a history of seizures (convulsions) or is at risk of seizures;
• In rare and unpredictable cases, the patient develops malignant hyperthermia (sudden and dangerously high body temperature during or shortly after surgery). In such a case, the anesthesiologist (doctor) will stop administering sevoflurane and administer dantrolene to counteract malignant hyperthermia and provide other supportive treatment. A case of malignant hyperthermia with a fatal outcome has been reported during the use of sevoflurane;
• The patient has a neuromuscular disease, such as Duchenne muscular dystrophy;
• The patient has a mitochondrial disorder.

Children

• In the case of children with Down syndrome

If any of the above points apply, you should confirm this with your doctor, nurse, or pharmacist. The patient may require thorough examinations, and treatment may be changed.

Other Medicines and Sevoflurane Baxter

You should tell your doctor, pharmacist, surgeon, or anesthesiologist about all medicines you are currently taking or have recently taken, as well as any medicines you plan to take. This also applies to herbal medicines and vitamins and minerals. The following medicines or active substances contained in these medicines may interact with the effects of Sevoflurane Baxter when used concurrently. Some of these medicines are administered during surgery by the anesthesiologist, as described.

• Nitrous oxide: a medicine used during general anesthesia that induces sleep and relieves pain;
• Opioids (e.g., morphine, fentanyl, remifentanil): strong painkillers, often used during general anesthesia;
• Non-depolarizing muscle relaxants (e.g., pancuronium, atracurium): medicines used during general anesthesia to relax muscles;
• Benzodiazepines (e.g., diazepam, lorazepam): sedatives, used to calm, for example, before surgery;
• Adrenaline: a medicine often used to counteract allergic reactions, but may also be used during general anesthesia;
• Verapamil: a heart medicine used to treat high blood pressure or heart rhythm disorders;
• Beta-blockers (e.g., atenolol, propranolol): heart medicines often used to treat high blood pressure;
• Medicines with indirect sympathomimetic action, 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 preparation used in depression.

Sevoflurane Baxter with Food and Drink

Sevoflurane Baxter is a medicine that induces and maintains sleep to allow surgery to be performed. You should ask your doctor, surgeon, or anesthesiologist when and what the patient will be able to eat or drink after waking up from anesthesia.

Pregnancy, Breastfeeding, and Fertility

If the patient is pregnant or breastfeeding, if she suspects she is pregnant, or plans to become pregnant, she should consult her doctor, surgeon, or anesthesiologist before using the medicine.

Driving and Using Machines

Sevoflurane Baxter has a strong effect on the ability to drive vehicles and use tools. You should not drive vehicles, use tools, or operate any mechanical equipment until your doctor considers it safe. Receiving an anesthetic may affect your perception for several days. It may also affect your ability to perform tasks that require intellectual performance. You should ask your anesthesiologist when you can safely drive vehicles and operate mechanical equipment again.

3. How to Use Sevoflurane Baxter

Sevoflurane Baxter will be administered by an anesthesiologist. The anesthesiologist will determine the appropriate dose and duration of administration for the patient. The dose will vary depending on the patient's age, weight, type of surgical procedure, and other medicines administered during surgery. Sevoflurane Baxter is produced from liquid sevoflurane in a device called a vaporizer, specifically designed for use with sevoflurane. Induction of anesthesia may be performed by inhaling sevoflurane vapor through a mask. The patient may also receive an injection of another anesthetic that will induce sleep before using Sevoflurane Baxter, administered through a mask or a tube in the throat. The anesthesiologist will decide when to stop administering Sevoflurane Baxter. Recovery occurs within a few minutes.

Using More Than the Recommended Dose of Sevoflurane Baxter

Sevoflurane Baxter will be administered by qualified medical personnel, and it is unlikely that the patient will receive too much Sevoflurane Baxter. If the patient receives too much Sevoflurane Baxter, the anesthesiologist will take all necessary measures.

4. Possible Side Effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. Most side effects are mild to moderate and short-lived, but severe side effects can also occur. Severe Side Effects(can be life-threatening)

• Anaphylaxis and anaphylactoid reactions (see Side Effects of Unknown Frequency for more information).

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

Very Common Side Effects (affects more than 1 in 10 patients)

• Agitation (restlessness and agitation)
• Bradycardia (slow heart rate)
• Decreased blood pressure
• Cough
• Nausea and vomiting

Common Side Effects (affects 1 to 10 in 100 patients)

• Drowsiness or feeling sleepy
• Headache
• Dizziness
• Increased heart rate
• High blood pressure
• Breathing difficulties
• Airway obstruction
• Slow and shallow breathing
• Laryngospasm
• 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 test
• Increased liver enzyme activity, detected in a blood test
• Elevated fluoride levels in the blood, detected in a blood test
• Decreased body temperature

Uncommon Side Effects (affects 1 to 10 in 1,000 patients)

• Confusion
• Palpitations or irregular heartbeat
• Atrioventricular block (disruption of electrical conduction in the heart)
• Apollo (respiratory arrest)
• Asthma
• Hypoxia (decreased oxygen levels in the blood)
• Elevated creatinine levels in the blood (indicator of impaired kidney function), detected in a blood test

Side Effects of Unknown Frequency (frequency cannot be estimated from available data)

• Allergic reactions, including:
• Rash
• Redness of the skin
• Hives
• Itching
• Swelling of the eyelids
• Breathing difficulties
• Anaphylaxis and anaphylactoid reactions. These allergic reactions occur quickly 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
• Hives
• Disorders of consciousness
• Seizure-like convulsions
• Myoclonic seizures
• Cardiac arrest
• Respiratory arrest
• Dyspnea
• Liver dysfunction or hepatitis, characterized by loss of appetite, fever, nausea, vomiting, abdominal pain, jaundice, and dark urine
• Life-threatening elevated body temperature
• Chest discomfort
• Increased intracranial pressure
• Irrregular heartbeat or palpitations
• Pancreatitis
• Increased potassium levels in the blood, detected in a blood test
• Muscle stiffness
• 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 the urine)
• Edema

Sometimes, seizure-like attacks have been observed. They can occur during administration of Sevoflurane Baxter or up to one day after anesthesia. They mainly occur in children and young adults. In children with Down syndrome who receive sevoflurane, bradycardia (slow heart rate) may occur. During or immediately after anesthesia, fluoride levels in the blood may be slightly elevated, but they are not considered harmful and quickly return to normal. If any of the side effects worsen or if you experience any side effects not listed in this leaflet, you should inform your doctor or pharmacist. If you notice any change in your condition after using sevoflurane, you should inform your doctor or pharmacist. Some side effects may require treatment.

Reporting Side Effects

If you experience any side effects, including those not listed in this leaflet, you should inform your doctor, surgeon, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products, Medical Devices, and Biocidal Products 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. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to Store Sevoflurane Baxter

The medicine should be stored out of 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. There are no special precautions for storage.

6. Contents of the Package and Other Information

What Does Sevoflurane Baxter Contain

The active substance of the medicine is sevoflurane 100% (250 ml in a 250 ml bottle). The product does not contain any other ingredients.

What Sevoflurane Baxter Looks Like and What the Package Contains

Sevoflurane is a clear, colorless liquid for inhalation vapor. It is supplied in 250 ml aluminum bottles with an internal protective coating. The bottle may be closed with a plastic cap or an integrated valve that connects directly to a suitable vaporizer. Package sizes: 1 or 6 bottles. Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

MARKETING AUTHORIZATION 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 Medicine is Authorized in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) Under the Following Names:

Date of Last Revision of the Leaflet: November 2023

Baxter is a trademark of Baxter International Inc.