Sugammadex Baxter

Package Leaflet: Information for the User

Sugammadex Baxter, 100 mg/ml, Solution for Injection

Sugammadex

Read all of this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any further questions, ask your anaesthetist or doctor.
• If you get any side effects, talk to your doctor or anaesthetist. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

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

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

What Sugammadex Baxter is

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

What Sugammadex Baxter is used for

In some types of surgery, the patient's muscles must be completely relaxed. This allows the surgeon to perform the surgery more easily. To achieve this, muscle relaxants are given during general anaesthesia. These are known as 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 Baxter is used to help the muscles recover more quickly after surgery, so that the patient can breathe on their own again sooner. It works by 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, and in children and adolescents (from 2 to 17 years old) when rocuronium bromide has been given for moderate to heavy muscle relaxation.

2. Important information before you are given Sugammadex Baxter

When not to use Sugammadex Baxter

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

Warnings and precautions

Before you are given Sugammadex Baxter, discuss this with your anaesthetist

Children

This medicine is not recommended for use in infants below 2 years of age.

Sugammadex Baxter and other medicines

→ Tell your anaesthetist about all medicines you are taking now or have taken recently, and about medicines you plan to take. Sugammadex Baxter may affect the way other medicines work or other medicines may affect the way Sugammadex Baxter works.

Some medicines may reduce the effect of Sugammadex Baxter

→ It is especially important to inform your anaesthetist if you have taken any of the following medicines recently:

• Toremifene (used to treat breast cancer).
• Fusidic acid (an antibiotic).

Sugammadex Baxter may affect the effectiveness of hormonal contraceptives

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

Effect on laboratory tests

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

Pregnancy and breast-feeding

→ Inform your anaesthetist if you are pregnant or think you may be pregnant, or if you are breast-feeding. You can still be given Sugammadex Baxter, but discuss this with your doctor. It is not known whether sugammadex passes into human milk. Your anaesthetist will help you decide whether to stop breast-feeding or avoid sugammadex, considering the benefit of breast-feeding to your baby and the benefit of Sugammadex Baxter to you.

Driving and using machines

Sugammadex Baxter has no known effect on the ability to drive or use machines.

Sugammadex Baxter contains sodium

The medicine contains up to 9.2 mg of sodium (the main ingredient of common salt) per millilitre. This is equivalent to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How Sugammadex Baxter is given

Sugammadex Baxter will be given to you by your anaesthetist or under the supervision of your anaesthetist.

Dose

Your anaesthetist will decide on the dose of sugammadex based on:

• your body weight
• the dose of muscle relaxant given. The usual dose is 2-4 mg/kg body weight for adults and children and adolescents (from 2 to 17 years old). If rapid recovery of muscle function is needed, a dose of 16 mg/kg body weight can be given to adults.

How Sugammadex Baxter is given

Sugammadex Baxter will be given by your anaesthetist as a single injection into a vein.

If more Sugammadex Baxter is given than recommended

Because your anaesthetist is closely monitoring your condition, it is unlikely that you will be given too much Sugammadex Baxter. However, if this happens, it is unlikely to cause any problems. If you have any further questions on the use of this medicine, ask your anaesthetist or doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur during anaesthesia, they will be noticed and treated by your anaesthetist.

Common side effects (may affect up to 1 in 10 people)

• Cough
• Difficulty breathing, including coughing or moving, such as when waking up or taking a breath
• Mild sedation - you may start to wake up from deep sleep and need more anaesthetic. This may cause movement or coughing at the end of surgery
• Complications during the procedure, such as changes in heart rate, coughing or moving
• Decreased blood pressure related to surgery

Uncommon side effects (may affect up to 1 in 100 people)

• Shortness of breath due to muscle spasm in the airways (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, shortness of breath, changes in blood pressure or heart rate, sometimes leading to severe low blood pressure. Severe allergic reactions or reactions similar to allergic reactions can be life-threatening. Allergic reactions have been reported more frequently in healthy, conscious volunteers
• Return of muscle relaxation after surgery

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

• After Sugammadex Baxter is given, severe cases of slow heart rate, including slow heart rate leading to cardiac arrest, are possible

Reporting of side effects

If you get any side effects, talk to your doctor or anaesthetist. This includes any possible side effects not listed in this leaflet. Side effects can be reported to the national reporting system via the Medicines Agency website (https://smz.ezdrowie.gov.pl). Side effects can also be reported to the marketing authorisation holder.

5. How to store Sugammadex Baxter

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. Store the vial in the outer carton in order to protect from light. After first opening and dilution, store in a refrigerator (2°C - 8°C) and use within 24 hours.

6. Contents of the pack and other information

What Sugammadex Baxter 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. Each 5 ml vial contains sugammadex sodium equivalent to 500 mg sugammadex.
• The other ingredients are water for injections, hydrochloric acid 3.2% (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

What Sugammadex Baxter looks like and contents of the pack

Sugammadex Baxter is a clear, colourless to light yellow-brown solution for injection. It may be available in two different pack sizes containing 10 vials of 2 ml or 10 vials of 5 ml solution for injection. Not all pack sizes may be marketed.

Marketing Authorisation Holder

Baxter Holding B.V. Kobaltweg 49, 3542 CE Utrecht, Netherlands

Manufacturer

Solupharm Pharmazeutische Erzeugnisse GmbH Industriestrasse 3, 34212 Melsungen, Germany For further information, contact your local representative of the Marketing Authorisation Holder: Baxter Polska Sp. z o.o. +48 22 488 37 77

This medicinal product is authorised in the Member States of the European Economic Area under the following names:

Country Name of the medicinal product

Ireland Sugammadex 100 mg/ml Solution for Injection Czech Republic Sugammadex Baxter Denmark Sugammadex Baxter Austria Sugammadex Baxter 100 mg/ml Injektionslösung Germany Sugammadex Baxter 100 mg/ml Injektionslösung Greece Sugammadex/Baxter Spain Sugammadex Baxter 100 mg/ml solución inyectable EFG Finland Sugammadex Baxter 100 mg/ml injektioneste, liuos France Sugammadex Baxter 100 mg/ml, solution injectable Italy Sugammadex Baxter Norway Sugammadex Baxter Belgium Sugammadex Baxter 100 mg/ml solution injectable Poland Sugammadex Baxter Portugal Sugamadex Baxter Romania Sugammadex Baxter 100 mg/ml soluție injectabilă Slovenia Sugamadeks Baxter 100 mg/ml raztopina za injiciranje Sweden Sugammadex Baxter Netherlands Sugammadex Baxter 100 mg/ml oplossing voor injectie

Date of last revision of the package leaflet:

Information intended for healthcare professionals only: For further information, refer to the Summary of Product Characteristics for Sugammadex Baxter.