Sugammadex Fresenius Kabi 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Sugammadex Fresenius Kabi 100 mg/ml solution for injection

sugammadex

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

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your anaesthesiologist (anaesthetist) or your doctor.
• If you get any side effects, talk to your anaesthetist or another doctor, even if it is not one of the side effects listed in this leaflet. See section 4.

Contents of this leaflet

1. What Sugammadex Fresenius Kabi is and what it is used for
2. What you need to know before administration of Sugammadex Fresenius Kabi
3. How Sugammadex Fresenius Kabi is administered
4. Possible side effects
5. How to store Sugammadex Fresenius Kabi
6. Contents of the pack and other information

1. What Sugammadex Fresenius Kabi is and what it is used for

What Sugammadex Fresenius Kabi is

Sugammadex Fresenius Kabi contains the active substance sugammadex. Sugammadex is considered a selective binding agent for neuromuscular blockers, as it only works with specific muscle relaxants, namely rocuronium bromide or vecuronium bromide.

What Sugammadex Fresenius Kabi is used for

When undergoing surgery, your muscles must be completely relaxed, which makes the surgical procedure easier for the surgeon. For this purpose, during general anesthesia you will be given medications to relax your muscles. These are called neuromuscular blocking agents, such as rocuronium bromide and vecuronium bromide. Since these medications also block the respiratory muscles, you will require assistance with breathing (mechanical ventilation) during and after surgery until you are able to breathe on your own again.

Sugammadex is used to accelerate muscle recovery after surgery, enabling you to breathe independently again sooner. It works by binding to rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide has been administered.

It can also be used in newborns, infants, children, and adolescents (from birth up to 17 years of age) when rocuronium bromide is used.

2. What you need to know before receiving Sugammadex Fresenius Kabi

Do not receive Sugammadex Fresenius Kabi

• if you are allergic to sugammadex or to any of the other components of this medicine (listed in section 6).

Inform your anaesthetist if this applies to you.

Warnings and precautions

Talk to your anaesthetist before receiving sugammadex

• if you have any kidney disease or have had kidney problems in the past. This is important because sugammadex is eliminated from your body through the kidneys.
• if you have liver disease or have had liver problems previously.
• if you have fluid retention (edema).
• if you have a condition that increases your risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Other medicines and Sugammadex Fresenius Kabi

Inform your anaesthetist if you are taking, have recently taken, or might need to take any other medicines.

Sugammadex may affect other medicines or may be affected by them.

Some medicines reduce the effect of Sugammadex Fresenius Kabi

It is especially important that you inform your anaesthetist if you have recently taken:

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

Sugammadex Fresenius Kabi may affect hormonal contraceptives

• Sugammadex Fresenius Kabi may reduce the effectiveness of hormonal contraceptives – such as the "Pill", vaginal ring, implants, or a hormonal intrauterine device (IUD-h) – because it reduces the amount of progestogen hormone available. The amount of progestogen lost due to sugammadex use is approximately the same as when a contraceptive pill is missed.

→ If you are taking the Pill on the same day that sugammadex is administered, follow the missed tablet instructions provided in the contraceptive pill’s package leaflet.

→ If you are using other hormonal contraceptives (e.g. vaginal ring, implant, or IUD-h), you should use an additional non-hormonal contraceptive method (such as a condom) for the following 7 days and follow the recommendations in the contraceptive’s package leaflet.

Effects on blood tests

In general, sugammadex has no known effects on laboratory tests. However, it may affect the results of a blood test measuring levels of the hormone progesterone. Consult your doctor if progesterone levels need to be tested on the same day you receive sugammadex.

Pregnancy and breastfeeding

Inform your anaesthetist if you are pregnant or think you may be pregnant, or if you are breastfeeding. You may still be given sugammadex, but this should be discussed beforehand.

It is unknown whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to interrupt breastfeeding or to avoid treatment with sugammadex, taking into account the benefits of breastfeeding for the baby and the benefits of sugammadex for the mother.

Driving and using machines

Sugammadex Fresenius Kabi has no known influence on the ability to drive or use machines.

Sugammadex Fresenius Kabi contains sodium

This medicine contains up to 9.7 mg of sodium (the main component of table/cooking salt) per ml. This corresponds to 0.5% of the maximum daily recommended intake of sodium for an adult.

3. How Sugammadex Fresenius Kabi is administered

Sugammadex Fresenius Kabi will be administered to you by your anaesthetist, or under the supervision of your anaesthetist.

Dosage

Your anaesthetist will calculate the dose of sugammadex you need based on:

• your body weight
• the amount of muscle relaxant still having an effect.

The usual dose is 2–4 mg per kg of body weight for patients of any age. A dose of 16 mg/kg may be used in adults if urgent reversal of muscle relaxation is required.

How Sugammadex Fresenius Kabi is administered

Sugammadex will be administered by your anaesthetist. It is given as a single intravenous injection.

If you are given more Sugammadex Fresenius Kabi than you should

As your anaesthetist will be carefully monitoring your condition, it is unlikely that you will be given too much sugammadex. However, even if this happens, it is unlikely to cause any problems.

If you have any further questions about the use of this medicine, ask your anaesthetist or another doctor.

4. Possible adverse effects

Like all medicines, this medicine may cause adverse effects, although not everybody gets them.

If these adverse effects occur while you are under anaesthesia, they will be detected and treated by your anaesthetist.

Frequent (may affect up to 1 in 10 people)

• Cough
• Respiratory tract difficulties which may include cough or movements as if awake or gasping for breath
• Superficial anaesthesia – you may start to wake up, so you will need more anaesthetic. This may cause you to move or cough at the end of the operation
• Complications during the procedure, such as changes in heart rate, coughing or movement
• Decrease in blood pressure due to the surgical intervention

Uncommon (may affect up to 1 in 100 people)

• Breathing difficulty due to muscle cramps in the airways (bronchospasm) occurring in patients with a history of lung problems
• Allergic reactions (hypersensitivity to the active substance) – such as rash, redness of the skin, swelling of the tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rhythm, which sometimes result in a severe drop in blood pressure. Allergy-type reactions or severe allergic reactions may be life-threatening
• Allergic reactions have been reported more frequently in healthy conscious volunteers
• Recurrence of muscle relaxation after surgery

Frequency not known

• When sugammadex is administered, a significant slowing of the heart may occur, which could even lead to cardiac arrest

Reporting of adverse effects

If you experience any adverse effects, consult your anaesthetist or another doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly through the national reporting system included in Appendix V. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Fresenius Kabi

Storage must be handled by healthcare professionals.

Keep this medicinal product out of the sight and reach of children.

Do not use this medicinal product after the expiry date stated on the carton and label, following "EXP". The expiry date refers to the last day of the stated month.

This medicinal product does not require any special storage temperature conditions. Do not freeze. Keep the vial in the outer packaging to protect it from light. After opening and dilution, store at 2–8 °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 and containers you no longer need. This will help protect the environment.

6. Pack contents and other information

Composition of Sugammadex Fresenius Kabi

• The active substance is sugammadex.

Each ml of injectable solution contains sodium sugammadex equivalent to 100 mg of sugammadex.

Each 1 ml vial contains sodium sugammadex equivalent to 100 mg of sugammadex.

Each 2 ml vial contains sodium sugammadex equivalent to 200 mg of sugammadex.

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

• The other components are water for injections, hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment). See section 2 “Sugammadex Fresenius Kabi contains sodium”.

Nature of the product and pack contents

Sugammadex Fresenius Kabi is a clear, particle-free injectable solution ranging from colourless to slightly yellow. It is available in three pack sizes containing 10 vials of 1 ml, 2 ml, or 5 ml of injectable solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Fresenius Kabi Deutschland GmbH

Else-Kröner-Straße 1,

61352 Bad Homburg v.d.Höhe

Germany

Manufacturer

Labesfal - Laboratórios Almiro, S.A.

Zona Industrial do Lagedo

3465-157 Santiago de Besteiros

Portugal

Further information on this medicinal product can be obtained by contacting the local representative of the Marketing Authorisation Holder.

Date of the most recent review of this leaflet

Detailed information on this medicinal product is available on the European Medicines Agency website: http://www.ema.europa.eu.

This information is intended for healthcare professionals only:

Sugammadex Fresenius Kabi may be administered via the same route as an ongoing infusion of the following intravenous solutions: sodium chloride 9 mg/ml (0.9%), glucose 50 mg/ml (5%), sodium chloride 4.5 mg/ml (0.45%) and glucose 25 mg/ml (2.5%), lactated Ringer's solution, Ringer's solution, and glucose 50 mg/ml (5%) in sodium chloride 9 mg/ml (0.9%).

The infusion line must be adequately flushed (e.g., with 0.9% sodium chloride solution) between administration of Sugammadex Fresenius Kabi and other medications.

Use in the paediatric population

For paediatric patients, Sugammadex Fresenius Kabi may be diluted with sodium chloride 9 mg/ml (0.9%) to a concentration of 10 mg/ml (see section 6.3).

Any unused medicinal product and materials that have come into contact with it must be disposed of in accordance with local regulations.

For further information, refer to the Summary of Product Characteristics or the Package Leaflet of Sugammadex Fresenius Kabi.