Sugammadex Aspen

Package Leaflet: Information for the User

Sugammadex Aspen, 100 mg/mL, Solution for Injection

Sugammadex

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

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

Table of Contents of the Package Leaflet

• 1. What is Sugammadex Aspen and what is it used for
• 2. Important information before using Sugammadex Aspen
• 3. How is Sugammadex Aspen administered
• 4. Possible side effects
• 5. How to store Sugammadex Aspen
• 6. Contents of the pack and other information

1. What is Sugammadex Aspen and what is it used for

What is Sugammadex Aspen

Sugammadex Aspen contains the active substance sugammadex. Sugammadex is considered a selective relaxant binding agentbecause it only acts on certain muscle relaxants – rocuronium bromide or vecuronium bromide.

What is Sugammadex Aspen used for

In some types of surgery, the patient's muscles must be completely relaxed. This allows the surgeon to perform the operation more easily. To achieve this, muscle relaxants are administered during general anesthesia. These are called muscle relaxantsand include rocuronium bromide and vecuronium bromide. Because these medications also cause relaxation of the respiratory muscles, assisted breathing (mechanical ventilation) is necessary during and after surgery until the patient regains their own breathing. Sugammadex Aspen is used to accelerate the recovery of muscle function after surgery, allowing the patient to breathe on their own sooner. Its action involves binding to rocuronium bromide or vecuronium bromide in the body. The medicine can be used in adults when rocuronium bromide or vecuronium bromide has been administered, as well as in children and adolescents (aged 2 to 17 years) when rocuronium bromide has been administered for moderate muscle relaxation.

2. Important information before using Sugammadex Aspen

When not to use Sugammadex Aspen

Warnings and precautions

Before administering Sugammadex Aspen, discuss with your anesthesiologist if:

• the patient currently has or has had kidney disease in the past. This is important because Sugammadex Aspen is eliminated from the body by the kidneys.
• the patient currently has or has had liver disease in the past.
• the patient has fluid retention in the body (edema).
• the patient has diseases that are known to increase the risk of bleeding (coagulation disorders) or is taking anticoagulant medications.

Children and adolescents

The use of this medicine is not recommended in children under 2 years of age.

Sugammadex Aspen and other medicines

Tell your anesthesiologist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Sugammadex Aspen may affect the action of other medicines or other medicines may affect the action of Sugammadex Aspen.

Some medicines reduce the effectiveness of Sugammadex Aspen

It is especially important to inform your anesthesiologist if the patient has recently taken:

• toremifene (used to treat breast cancer)
• fusidic acid (an antibiotic).

Sugammadex Aspen may affect the effectiveness of hormonal contraceptives

• Sugammadex Aspen may reduce the effectiveness of hormonal contraceptives, including "the pill", vaginal ring, implant, or intrauterine system releasing progestogen (hormonal intrauterine device), as it reduces the amount of hormone delivered. The amount of progestogen lost due to the use of Sugammadex Aspen is roughly equivalent to missing one contraceptive pill. If taking "the pill" on the same day Sugammadex Aspen is administered, follow the instructions for missing a pill in the hormonal contraceptive package leaflet. For other hormonal contraceptives (such as vaginal ring, implant, or hormonal intrauterine device), use an additional non-hormonal contraceptive method (e.g., condoms) for the next 7 days and follow the recommendations in the package leaflet of the contraceptive.

Effect on laboratory test results

Usually, Sugammadex Aspen does not affect laboratory test results. However, it may affect the results of blood tests for a hormone called progesterone. Inform your doctor if the progesterone level in the blood should be tested on the same day Sugammadex Aspen is administered.

Pregnancy and breastfeeding

If the patient is pregnant, thinks she may be pregnant, or is breastfeeding, she should inform her anesthesiologist. The patient can still be given Sugammadex Aspen, but this should be discussed with the doctor first. It is not known whether sugammadex passes into breast milk. The anesthesiologist will help the patient decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefits of breastfeeding for the baby and the benefits of treatment with Sugammadex Aspen for the mother.

Driving and using machines

The effect of Sugammadex Aspen on the ability to drive and use machines is not known.

Sugammadex Aspen contains sodium

The medicine contains up to 9.5 mg of sodium (the main component of common salt) per milliliter. This corresponds to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How is Sugammadex Aspen administered

Sugammadex Aspen will be administered to the patient by an anesthesiologist or under the supervision of an anesthesiologist.

Dose

The anesthesiologist will adjust the dose of Sugammadex Aspen based on:

• the patient's body weight
• the severity of the muscle relaxant effect in the patient.

The usual dose is 2-4 mg/kg body weight in adults and children and adolescents aged 2 to 17 years. If rapid recovery of muscle function is necessary, a dose of 16 mg/kg body weight can be used in adults.

How Sugammadex Aspen is administered

Sugammadex Aspen is administered by an anesthesiologist. It is given as a single injection through an intravenous line.

Overdose of Sugammadex Aspen

Because the anesthesiologist closely monitors the patient's condition, it is unlikely that Sugammadex Aspen will be overdosed. Nevertheless, in the event of such an occurrence, no problems should arise. If you have any further questions about the use of this medicine, ask your anesthesiologist or another doctor.

4. Possible side effects

Like all medicines, Sugammadex Aspen can cause side effects, although not everybody gets them. If any of the following side effects occur during anesthesia, they will be noticed and treated by the anesthesiologist.

Frequent side effects (may occur in less than 1 in 10 people)

• Cough.
• Difficulty breathing, including coughing or moving, such as when waking up or taking a breath.
• Mild anesthesia - the patient may start waking up from deep sleep and therefore need more anesthetic. This may result in movement or coughing at the end of the operation.
• Complications during the procedure, such as changes in heart rate, coughing, or moving.
• Decreased blood pressure related to the surgical procedure

Uncommon side effects (may occur in less than 1 in 100 people)

• Shortness of breath associated with bronchospasm (bronchospasm) in patients with a history of lung disease.

• Allergic reactions (hypersensitivity to the medicine) - such as rash, skin redness, tongue and/or throat swelling, shortness of breath, changes in blood pressure or heart rhythm, sometimes resulting in severe hypotension. Severe allergic reactions or anaphylactoid reactions may be life-threatening. The occurrence of allergic reactions has been reported more frequently in healthy, conscious volunteers.
• Return of muscle relaxation after surgery.

Frequency not known

• After administration of Sugammadex Aspen, severe cases of bradycardia, as well as bradycardia, up to cardiac arrest, are possible.

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your anesthesiologist or another doctor. Side effects can be reported directly to the Department of Medicinal Product Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181 C, 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 Sugammadex Aspen

The medicine will be stored by healthcare professionals. Store the medicine out of sight and reach of children. Do not use this medicine after the expiry date stated on the carton and label of the vial after "EXP". The expiry date refers to the last day of the month stated. Do not store above 30°C. Do not freeze. Store the vials in the outer packaging to protect from light. After first opening and dilution, the chemical and physical stability of the ready-to-use solution has been demonstrated for 48 hours at a temperature of 2°C to 25°C. From a microbiological point of view, the diluted product should be used immediately. If the medicine is not used immediately, the storage times and conditions before use are the responsibility of the user and are usually not longer than 24 hours at a temperature of 2°C to 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions. Do not use this medicine if you notice any visible signs of deterioration.

6. Contents of the pack and other information

What Sugammadex Aspen contains

• The active substance is sugammadex. 1 mL of the solution for injection contains sugammadex sodium equivalent to 100 mg of sugammadex. Each 2 mL vial contains sugammadex sodium equivalent to 200 mg of sugammadex.

Each 5 mL vial contains sugammadex sodium equivalent to 500 mg of sugammadex.

• The other ingredients are: water for injections, hydrochloric acid, and/or sodium hydroxide.

What Sugammadex Aspen looks like and contents of the pack

Sugammadex Aspen is a clear solution for injection, colorless to slightly yellow-brown, free from visible particles. It is available in two different pack sizes containing 10 vials of 2 mL or 10 vials of 5 mL of solution for injection, in a cardboard box. Not all pack sizes may be marketed.

Marketing authorization holder

Aspen Pharma Trading Limited, 3016 Lake Drive, Citywest Business Campus, Dublin 24, Ireland, tel. 0048 22 104 21 00

Manufacturer

Pharmidea, 4 Rupnicu Street, Olaine, Olaine district, LV-2114, Latvia; Medichem S.A., Narcís Monturiol 41A, 08970 Sant Joan Despí - Barcelona, Spain

Manufacturer/Importer

Combino Pharm Malta Ltd., HF60 Hal Far Industrial Estate, Hal Far, BBG3000, Malta

Date of last revision of the package leaflet:

Information intended for healthcare professionals only:

For detailed information, refer to the Summary of Product Characteristics of Sugammadex Aspen.