AERRANE 100% Liquid

Contents of the leaflet

1. Leaflet attached to the packaging: information for the user
2. AERRANE, 100%, inhalation anesthesia liquid
   1. Read the leaflet carefully before using the medicine, as it contains important information for the patient.
   2. Table of contents of the leaflet:
3. What is AERRANE and what is it used for
4. Important information before using AERRANE
   1. When not to use AERRANE:
   2. Warnings and precautions
   3. The doctor will monitor the patient's breathing during the administration of AERRANE, especially if the patient is taking other medicines that may affect breathing, such as:
   4. AERRANE and other medicines
   5. AERRANE with food, drink, and alcohol
   6. Pregnancy and breastfeeding
   7. Driving and using machines
5. How to use AERRANE
   1. Overdose of AERRANE
6. Possible side effects
   1. Tell your doctor, nurse, or pharmacist as soon as possible if you experience any of the following side effects, which may be serious.
   2. Reporting side effects
7. How to store AERRANE
8. Package contents and other information
   1. What AERRANE contains
   2. What AERRANE looks like and what the package contains
   3. Marketing authorization holder and manufacturer
   4. Marketing authorization holder:
   5. Manufacturer:
   6. Date of last revision of the leaflet: October 2017

Leaflet attached to the packaging: information for the user

AERRANE, 100%, inhalation anesthesia liquid

Isoflurane

Read the leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• If you have any doubts, consult a doctor, nurse, or pharmacist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. See section 4.

Table of contents of the leaflet:

• 1. What is AERRANE and what is it used for
• 2. Important information before using AERRANE
• 3. How to use AERRANE
• 4. Possible side effects
• 5. How to store AERRANE
• 6. Package contents and other information

1. What is AERRANE and what is it used for

AERRANE contains isoflurane. It is used in surgery for general anesthesia. It is an inhalation anesthetic (administered to the patient as a vapor to be inhaled). Inhaling isoflurane vapors causes the patient to fall into a deep sleep without feeling pain. It is also used to maintain deep sleep without feeling pain (general anesthesia) during which the patient can undergo surgery.

2. Important information before using AERRANE

When not to use AERRANE:

• if the patient is allergic (hypersensitive) to isoflurane or other inhalation anesthetics such as desflurane, sevoflurane, halothane, and enflurane;
• if the patient or any of their relatives have malignant hyperthermia. Malignant hyperthermia occurs when the patient's body temperature suddenly and dangerously increases during or shortly after surgery;
• if the patient has previously been anesthetized with AERRANE or another inhalation anesthetic (e.g., desflurane, sevoflurane, halothane) and experienced:
• liver problems,
• jaundice (yellowing of the skin and whites of the eyes),
• fever of unknown origin,
• increased white blood cell count - leukocytosis,
• increased count of a specific type of white blood cell - eosinophils (eosinophilia).

AERRANE must not be administered during operations on pregnant women, during childbirth, and immediately after childbirth. However, AERRANE may be used during a cesarean section.

AERRANE should not be used during dental procedures outside the hospital or outpatient clinics.

If any of the above conditions apply to the patient, the doctor, surgeon, or anesthesiologist should be informed before starting the administration of this medicine.

Warnings and precautions

Before starting AERRANE, consult a doctor, nurse, or pharmacist.

The doctor will exercise particular caution when using this medicine if:

• the patient has mitochondrial disease (a condition affecting the functioning of cells).
• the patient has liver diseases such as:
• hepatitis,
• liver cirrhosis (replacement of healthy liver tissue with scar tissue). This occurs in cases of excessive alcohol consumption.
• other liver diseases.
• the patient is at risk of changes in heart rhythm (prolonged QT interval in the ECG), which can lead to life-threatening arrhythmia of the torsade de pointes type.
• the patient has recently undergone surgery that required general anesthesia using an inhalation anesthetic.
• the patient has symptoms of a disease other than those related to the surgery, such as: severe headaches, nausea, vomiting, severe chest pain, or a condition affecting the muscles (neuromuscular disease, e.g., Duchenne muscular dystrophy or myasthenia gravis).
• the patient has bronchospasm (bronchospasm and narrowing of the airways, causing coughing, wheezing, or shortness of breath).
• the patient is a child under 2 years of age.

There may be a need for the doctor to administer a lower dose of AERRANE:

• if the patient has low blood volume (hypovolemia),
• if the patient has low blood pressure (hypotension),
• if the patient is weakened (exhausted).

AERRANE may cause irritation of the mucous membranes of the mouth and respiratory tract, leading to increased saliva and tracheal and upper respiratory secretions. In children, this may make breathing difficult or cause laryngospasm (a condition affecting the vocal cords).

In patients who have received AERRANE, the following may occur:

• temporary changes in liver function,
• increased blood glucose levels,
• decreased blood cholesterol levels,
• changes in blood enzyme activity.

AERRANE may cause malignant hyperthermia (a condition where the patient's body temperature suddenly and dangerously increases during or shortly after surgery). There have been reports of malignant hyperthermia with a fatal outcome associated with AERRANE.

The doctor will monitor the patient's breathing during the administration of AERRANE, especially if the patient is taking other medicines that may affect breathing, such as:

• sedatives (e.g., diazepam, nitrazepam),
• strong painkillers (e.g., opioids such as fentanyl, morphine, and remifentanil).

The medicine significantly enhances the effect of muscle relaxants (see below). If any of the above conditions apply to the patient (including children), consult a doctor, nurse, or pharmacist. It may be necessary to thoroughly examine the patient and change the treatment.

AERRANE and other medicines

Tell your doctor, nurse, or pharmacist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. This includes medicines that are available without a prescription, including herbal preparations and natural products.

Particular caution is advised when using any of the following medicines with AERRANE:

• non-selective MAO inhibitors (monoamine oxidase inhibitors such as phenelzine, isocarboxazid): the doctor will inform you that you should stop taking these medicines 15 days before the scheduled surgery.
• cardiac medicines - β-sympathomimetics (e.g., isoprenaline) and α- and β-sympathomimetics (e.g., adrenaline, noradrenaline): they may increase heart rate and cause severe arrhythmias.
• β-adrenergic blockers (e.g., atenolol, metoprolol): these are cardiac medicines often used to treat high blood pressure.
• isoniazid: used to treat tuberculosis. The doctor will inform you that you should stop taking isoniazid one week before the scheduled surgery. Do not restart taking isoniazid until the 15th day after the operation.
• sympathomimetic medicines with indirect action, e.g.,:
• amphetamines, amphetamine derivatives (used to treat ADHD - attention deficit hyperactivity disorder),
• appetite suppressants,
• ephedrine and ephedrine derivatives (common ingredients in cough and cold medicines). These medicines may increase the risk of high blood pressure if used with AERRANE. The doctor will inform you whether and when to stop taking these medicines.
• muscle relaxants (e.g., suxamethonium, pancuronium, atracurium, vecuronium). These medicines are used during general anesthesia to relax the patient's muscles. It may be necessary to reduce the dose of these medicines by the anesthesiologist.
• opioids (e.g., morphine, fentanyl, remifentanil): these are strong painkillers and are often used in general anesthesia.
• calcium antagonists: medicines used to treat high blood pressure (e.g., felodipine, nicardipine).

If the patient is unsure whether any of the above applies to them, consult a doctor, nurse, or pharmacist before using AERRANE.

AERRANE with food, drink, and alcohol

AERRANE is a medicine that induces sleep and maintains it, allowing the patient to undergo surgery. Ask your doctor, surgeon, or anesthesiologist when and what you can eat and drink after waking up. Do not drink alcohol. The doctor will inform you when it is possible to consume alcohol again.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks they may be pregnant, or plans to have a child, consult a doctor, surgeon, or anesthesiologist before using this medicine.

Due to the limited amount of data on the use of AERRANE in pregnant women, it is only administered to them when the benefits outweigh the risks.

However, smaller doses of AERRANE can be used during a cesarean section.

Since it is not known whether AERRANE passes into breast milk, breastfeeding should be avoided after surgery if the patient has been given AERRANE for general anesthesia.

Driving and using machines

Do not drive or operate tools and machines for at least 24 hours after surgery in which AERRANE was administered. Taking an anesthetic can affect the patient's alertness and behavior, which can negatively impact their ability to perform daily activities for up to 6 days. The patient should ensure they have transportation home.

3. How to use AERRANE

AERRANE is ALWAYS administered to the patient by an anesthesiologist, who decides on the dose of the medicine based on the patient's age, weight, and the type of surgery being performed.

If the patient is a child, they should be closely monitored during the administration of isoflurane.

Inducing sleep at the beginning of anesthesia

Isoflurane is not recommended for inducing sleep in infants and children.

Treatment used before anesthesia

The anesthesiologist may decide to use a treatment in children to counteract potential decreases in breathing rate and changes in heart rate that may occur with the use of isoflurane.

AERRANE is obtained from liquid isoflurane using a vaporizer. The patient can take AERRANE in one of two ways:

• before administering AERRANE through a mask, the patient may be injected with another anesthetic to induce sleep. This method of administering AERRANE is most commonly used;

or

• the patient may be asked to inhale isoflurane vapors through a mask to induce sleep. The patient will quickly and easily fall asleep. This method of administering AERRANE is used less frequently.

After the operation, the anesthesiologist will stop administering AERRANE. The patient will wake up within a few minutes.

Overdose of AERRANE

In case of an overdose of AERRANE, the administration of the medicine will be stopped.

The patient will be given pure oxygen. Blood pressure and heart function will be closely monitored during the patient's awakening.

If you have any further doubts about the use of this medicine, consult a doctor, pharmacist, or nurse.

4. Possible side effects

Like all medicines, AERRANE can cause side effects, although not everybody gets them.

Most side effects are mild to moderate and occur for a short time, but some severe side effects can also occur.

If an adult or child patient experiences unusual or unexpected symptoms after surgery, tell your doctor or anesthesiologist IMMEDIATELY.

The most commonly reported side effects are:

• bronchospasm, laryngospasm, causing breathing difficulties,
• increased glucose or potassium levels in the blood. Rare cases of abnormal heart rhythm (arrhythmia) and death have been reported in children shortly after surgery, associated with the use of inhalation anesthetics.

Tell your doctor, nurse, or pharmacist as soon as possible if you experience any of the following side effects, which may be serious.

Side effects of unknown frequency (i.e., frequency cannot be estimated from the available data):

• anaphylactic reactions,
• hypersensitivity,
• contact dermatitis,
• facial edema,
• rash,
• agitation,
• delirium,
• mood changes, sometimes extreme,
• seizures,
• intellectual impairment,
• arrhythmias, including life-threatening torsade de pointes type,
• abnormal ECG, changes in heart rhythm and rate,
• cardiac arrest,
• too slow or too fast heart rate,
• hypotension,
• bleeding (uncontrolled bleeding),
• liver damage (liver necrosis) or abnormal liver function (hepatocellular damage),
• nausea and vomiting,
• slow, shallow breathing (respiratory depression), dyspnea, wheezing,
• chest discomfort,
• increased white blood cell count,
• abnormal levels of certain substances in the blood (increased bilirubin, increased creatinine, decreased urea, decreased cholesterol),
• increased liver enzyme activity,
• increased fluoride (formed by the breakdown of isoflurane) or carbon monoxide levels in the blood,
• malignant hyperthermia, characterized by high body temperature,
• feeling cold, chills,
• temporary cessation of intestinal motility (intestinal obstruction), causing discomfort, bloating, and vomiting,
• abnormal EEG results,
• presence of myoglobin (a protein found in muscles) in the urine,
• muscle breakdown.

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring 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

e-mail: [email protected].

Side effects can also be reported to the marketing authorization holder.

Reporting side effects will help gather more information on the safety of this medicine.

5. How to store AERRANE

Store the medicine out of sight and reach of children.

There are no special precautions for storage.

Do not use this medicine after the expiry date stated on the label. The expiry date refers to the last day of the month.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What AERRANE contains

The active substance is isoflurane.

AERRANE does not contain any other ingredients.

What AERRANE looks like and what the package contains

AERRANE is a liquid.

AERRANE is supplied in bottles of 100 ml and 250 ml with a screw cap.

1 bottle of 100 ml

1 bottle of 250 ml

6 bottles of 100 ml

6 bottles of 250 ml

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

Manufacturer:

Baxter S.A.

Boulevard René Branquart 80

7860 Lessines

Belgium

To obtain more detailed information, contact the local representative of the marketing authorization holder:

Baxter Polska Sp. z o.o.

ul. Kruczkowskiego 8

00-380 Warsaw

Date of last revision of the leaflet: October 2017

Baxter and Aerrane are trademarks of Baxter International Inc.