SUGAMMADEX FRESENIUS KABI 100 mg/ml INJECTABLE SOLUTION

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 further questions, ask your anaesthetist or doctor.
• If you get any side effects, talk to your anaesthetist or doctor. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the pack

1. What Sugammadex Fresenius Kabi is and what it is used for
2. What you need to know before you are given Sugammadex Fresenius Kabi
3. How Sugammadex Fresenius Kabi is given
4. Possible side effects
5. Storage of 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 relaxant binding agentas it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex Fresenius Kabi is used for

If you have to undergo surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. For this, you will be given medicines during general anaesthesia to relax your muscles. These are called muscle relaxants, such as rocuronium bromide and vecuronium bromide. Since these medicines also block the respiratory muscles, you will need help breathing (artificial respiration) during and after surgery until you can breathe on your own again.

Sugammadex is used to speed up the recovery of your muscles after surgery so that you can breathe on your own again sooner. It does this by binding to rocuronium bromide or vecuronium bromide in your body. It can be used in adults when rocuronium bromide or vecuronium bromide is used.

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

2. What you need to know before you are given Sugammadex Fresenius Kabi

Do not receive Sugammadex Fresenius Kabi

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

Tell your anaesthetist if this applies to you.

Warnings and precautions

Consult your anaesthetist before you are given sugammadex

• if you have any kidney disease or have had it in the past. This is important because sugammadex is removed from your body by the kidneys.
• if you have any liver disease or have had it before.
• if you have fluid retention (oedema).
• if you have any disease that increases the risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Other medicines and Sugammadex Fresenius Kabi

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

Sugammadex may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex Fresenius Kabi

It is especially important that you tell your anaesthetist if you have taken any of the following recently:

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

Sugammadex Fresenius Kabi may affect hormonal contraceptives

• Sugammadex Fresenius Kabi may make hormonal contraceptives - such as the "Pill", vaginal ring, implants, or an Intrauterine Hormonal Device (IUD) - less effective because it reduces the amount of progestogen that reaches you. The amount of progestogen lost due to the use of sugammadex is approximately the same as that lost when you miss a birth control pill.

→ If you are taking the Pillon the same day that you are given sugammadex, follow the instructions for a missed pill in the pill leaflet.

→ If you are using otherhormonal contraceptives (e.g. vaginal ring, implant, or IUD), you should use a non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the leaflet.

Effects on blood tests

Generally, sugammadex does not affect laboratory tests. However, it may affect the results of a blood test when progesterone levels are measured. Consult your doctor if your progesterone levels need to be tested on the same day that you receive sugammadex.

Pregnancy and breast-feeding

Tell your anaesthetist if you are pregnant or think you may be pregnant or if you are breast-feeding. You may still be given sugammadex, but this needs to be discussed beforehand.

It is not known if sugammadex passes into breast milk. Your anaesthetist will help you decide whether to stop breast-feeding or avoid treatment with sugammadex, considering the benefit of breast-feeding to the baby and the benefit of sugammadex to the mother.

Driving and using machines

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

Sugammadex Fresenius Kabi contains sodium

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

3. How Sugammadex Fresenius Kabi is given

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

Dose

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

• your weight
• the amount of muscle relaxant that is still affecting you.

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 recovery of muscle relaxation is needed.

How Sugammadex Fresenius Kabi is given

Sugammadex will be given to you by your anaesthetist. It is injected once into a vein.

If you are given more Sugammadex Fresenius Kabi than recommended

Since your anaesthetist will be carefully monitoring the situation, it is unlikely that you will be given too much sugammadex. But even 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 while you are under anaesthesia, it will be your anaesthetist who detects and treats them.

Common (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if waking up or taking a breath
• Light anaesthesia – you may start to wake up, so you may 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, cough, or movement
• Decrease in blood pressure due to surgery

Uncommon (may affect up to 1 in 100 people)

• Difficulty breathing due to muscle spasms in the airways (bronchospasm) that occur in patients with a history of lung problems
• Allergic reactions (hypersensitivity to the active substance) - such as rash, redness of the skin, swelling of your tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rate, which sometimes result in a severe drop in blood pressure. Allergic reactions or severe allergic reactions can be life-threatening
• Allergic reactions were reported more frequently in healthy conscious volunteers
• Reappearance of muscle relaxation after surgery

Frequency not known

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

Reporting of side effects

If you experience any side effects, talk to your anaesthetist or doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Fresenius Kabi

Storage will be the responsibility of 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 on the label after “EXP”. The expiry date refers to the last day of the month shown.

This medicine does not require any special storage conditions. Do not freeze. Store the vial in the outer packaging to protect it from light. After opening and dilution, store at 2-8 ºC 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 Fresenius Kabi contains

• The active substance is sugammadex.

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

Each 1 ml vial 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 (for pH adjustment), sodium hydroxide (for pH adjustment). See section 2 “Sugammadex Fresenius Kabi contains sodium”.

Appearance and packaging

Sugammadex Fresenius Kabi is a clear, colourless to slightly yellowish solution for injection, free from visible particles. It is available in three different pack sizes containing 10 vials of 1 ml, 2 ml, or 5 ml of solution for injection.

Not all 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

You can request more information about this medicine from the local representative of the Marketing Authorisation Holder.

Date of last revision of this leaflet

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu.

This information is intended only for healthcare professionals:

Sugammadex Fresenius Kabi can be injected using the same line as for an ongoing infusion with 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%), Ringer’s lactate solution, Ringer’s solution and glucose 50 mg/ml (5%) in sodium chloride 9 mg/ml (0.9%).

The infusion line should be flushed properly (e.g. with sodium chloride 0.9% solution) between administration of Sugammadex Fresenius Kabi and other medicines.

Use in the paediatric population

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

Disposal of unused medicine and all materials that have come into contact with it should be done according to local regulations.

For detailed information, consult the Summary of Product Characteristics or the Package Leaflet of Sugammadex Fresenius Kabi.

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