Sugammadex Orion

Package Leaflet: Information for the User

Sugammadex Orion, 100 mg/ml, Solution for Injection

Sugammadex

Read the package leaflet carefully before the medicine is given, 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 anaesthesiologist or another doctor.
• If you experience any side effects, including any not listed in this package leaflet, tell your anaesthesiologist or another doctor. See section 4.

Table of Contents of the Package Leaflet

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

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

What is Sugammadex Orion

Sugammadex Orion contains the active substance sugammadex. Sugammadex Orion is considered a selective relaxant binding agentbecause it only works with certain muscle relaxants - rocuronium bromide or vecuronium bromide.

What is Sugammadex Orion 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 given during general anaesthesia. These are called muscle relaxantsand include rocuronium bromide and vecuronium bromide. Because these medicines also cause relaxation of the respiratory muscles, assisted breathing (artificial ventilation) is necessary during and after surgery until the patient's own breathing returns. Sugammadex Orion is used to speed up the recovery of the muscles after surgery, so that the patient can breathe on their own again 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 given. It can be used in newborns, infants, small children, children, and adolescents (from birth to 17 years) when rocuronium bromide has been given.

2. Important information before you are given Sugammadex Orion

When not to use Sugammadex Orion

• if you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6). In this case, inform your anaesthesiologist.

Warnings and precautions

Before Sugammadex Orion is given, discuss this with your anaesthesiologist

• if you have had kidney disease in the past. This is important because Sugammadex Orion is removed from the body through the kidneys.
• if you have had liver disease in the past or currently have liver disease
• if you have fluid retention in your body (oedema)
• if you have conditions that increase the risk of bleeding (blood clotting disorders) or are taking anticoagulant medicines.

Sugammadex Orion and other medicines

Tell your anaesthesiologist about all medicines you are taking or have recently taken, as well as any medicines you plan to take. Sugammadex Orion may affect the action of other medicines, or other medicines may affect the action of Sugammadex Orion. Some medicines reduce the effectiveness of Sugammadex Orion. It is especially important to inform your anaesthesiologist if you have taken the following medicines recently:

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

Sugammadex Orion may affect the effectiveness of hormonal contraceptives

• Sugammadex Orion may reduce the effectiveness of hormonal contraceptives, including the "pill", vaginal ring, implant, or intrauterine system that releases progestogen (hormonal intrauterine device), because it reduces the amount of hormone delivered. The amount of progestogen lost due to Sugammadex Orion is roughly equivalent to missing one contraceptive pill. → If you are taking the "pill" on the same day that Sugammadex Orion is given, follow the instructions for missing a pill in the package leaflet for your hormonal contraceptive. → If you are using other hormonal contraceptives (such as a vaginal ring, implant, or intrauterine system), use an additional non-hormonal contraceptive method (such as condoms) for the next 7 days and follow the instructions in the package leaflet for your contraceptive.

Effect on laboratory tests

Sugammadex Orion usually does not affect laboratory test results. However, it may affect the results of blood tests for a hormone called progesterone. If your progesterone level is to be tested on the same day that Sugammadex Orion is given, inform your doctor.

Pregnancy and breastfeeding

Inform your anaesthesiologist if you are pregnant or think you may be pregnant, or if you are breastfeeding. Sugammadex Orion can still be used in pregnant women, but this should be discussed with your doctor first. It is not known whether sugammadex passes into breast milk. Your anaesthesiologist will help you decide whether to stop breastfeeding or avoid treatment with Sugammadex Orion, considering the benefits of breastfeeding for your baby and the benefits of treatment with Sugammadex Orion for you.

Driving and using machines

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

Sugammadex Orion contains sodium

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

3. How Sugammadex Orion is given

Sugammadex Orion will be given to you by your anaesthesiologist or under the supervision of your anaesthesiologist.

Dose

Your anaesthesiologist will adjust the dose of Sugammadex Orion based on:

• your body weight
• the dose of muscle relaxant given.

The usual dose is from 2 mg/kg body weight to 4 mg/kg body weight in patients of all ages. If rapid recovery of muscle function is needed, a dose of 16 mg/kg body weight can be given to adults.

How Sugammadex Orion is given

Sugammadex Orion is given by your anaesthesiologist. It is given as a single injection through a vein.

If more Sugammadex Orion is given than recommended

Because your anaesthesiologist closely monitors your condition, it is unlikely that you will be given too much Sugammadex Orion. However, if this happens, no problems should occur. If you have any further questions about the use of this medicine, ask your anaesthesiologist or another doctor.

4. Possible side effects

Like all medicines, Sugammadex Orion can cause side effects, although not everybody gets them. If these side effects occur during anaesthesia, they will be noticed and treated by your anaesthesiologist. Common (may affect up to 1 in 10 people)

• cough
• breathing difficulties, including cough or movement, such as during emergence or taking a breath
• mild anaesthesia - the patient may start to wake up from deep sleep and, therefore, need more anaesthetic. This may result in movement or cough towards the end of surgery.
• complications during the procedure, such as changes in heart rate, cough, or movement
• decreased blood pressure related to the surgical procedure.

Uncommon (may affect up to 1 in 100 people)

• shortness of breath due to bronchospasm in patients with a history of lung disease
• allergic reactions (hypersensitivity to the medicine) - such as rash, skin redness, swelling of the tongue and/or throat, difficulty breathing, changes in blood pressure or heart rate, sometimes resulting in severe low blood pressure. Severe allergic reactions or anaphylaxis can be life-threatening. Allergic reactions have been reported more frequently in healthy, conscious volunteers.

Rare (may affect up to 1 in 1,000 people)

• return of muscle relaxation after surgery.

Frequency not known (cannot be estimated from the available data)

• severe bradycardia (slow heart rate) and asystole (flatline) have been reported after Sugammadex Orion administration.

Reporting of side effects

If you experience any side effects, including any not listed in this package leaflet, tell your anaesthesiologist or another doctor. Side effects can be reported directly to the Department of Drug Safety, 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 authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex Orion

The medicine will be stored by healthcare professionals. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and label after "EXP". The expiry date refers to the last day of that month. Do not freeze. Store the vials in the outer carton to protect from light. After first opening and dilution, store in a refrigerator (2°C - 8°C) and use within 24 hours. 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. Contents of the pack and other information

What Sugammadex Orion contains

• The active substance is sugammadex. 1 ml of solution for injection contains sugammadex sodium equivalent to 100 mg sugammadex. Each 2 ml vial contains sugammadex sodium equivalent to 200 mg sugammadex.
• The other ingredients are: hydrochloric acid (to adjust pH), sodium hydroxide (to adjust pH), and water for injections.

What Sugammadex Orion looks like and contents of the pack

Sugammadex Orion is a clear solution for injection, colourless to slightly yellow, practically free from particles. Pack sizes: 10 vials of 2 ml.

Marketing authorisation holder

Orion Corporation, Orionintie 1, FI-02200 Espoo, Finland

Manufacturer

Orion Corporation, Orion Pharma, Orionintie 1, FI-02200 Espoo, Finland, Orion Corporation, Orion Pharma, Joensuunkatu 7, FI-24100 Salo, Finland. For further information about this medicine, contact the local representative of the marketing authorisation holder: Orion Pharma Poland Sp. z o.o., [email protected], Date of last revision of the package leaflet:05/2025

Information intended for healthcare professionals only:

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