SUGAMMADEX AMOMED 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Amomed 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 is Sugammadex Amomed and what is it used for
2. What you need to know before you are given Sugammadex Amomed
3. How Sugammadex Amomed is given
4. Possible side effects
5. Storage of Sugammadex Amomed
6. Contents of the pack and other information

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

What is Sugammadex Amomed

Sugammadex Amomed contains the active substance sugammadex. Sugammadex Amomed is considered a selective relaxant binding agent as it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex Amomed is used for

If you need to have an operation, your muscles must be completely relaxed, which makes the operation easier for the surgeon. To achieve this, you will be given medicines during general anaesthesia to relax your muscles. These are called muscle relaxants and examples include rocuronium bromide and vecuronium bromide. Since these medicines also block the muscles used for breathing, you will need help with breathing (artificial respiration) during and after the operation until you can breathe on your own again. Sugammadex Amomed is used to speed up the recovery of your muscles after an operation 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 and in children and adolescents (from 2 to 17 years of age) when rocuronium bromide is used for moderate muscle relaxation.

2. What you need to know before you are given Sugammadex Amomed

You should not be given Sugammadex Amomed

• 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

Tell your anaesthetist before you are given Sugammadex Amomed

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

Children and adolescents

This medicine is not recommended for children under 2 years of age.

Other medicines and Sugammadex Amomed

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

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

Some medicines reduce the effect of Sugammadex Amomed

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

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

Sugammadex Amomed may affect hormonal contraceptives

• Sugammadex Amomed 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 Amomed is approximately the same as when you miss a contraceptive pill.

→ If you are taking the Pill on the same day that you are given Sugammadex Amomed, follow the instructions in the Pill leaflet in case of a missed pill.

→ If you are using other hormonal 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

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

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 Amomed, but this needs to be discussed beforehand.

It is not known whether sugammadex can pass into breast milk. Your anaesthetist will help you decide whether to stop breast-feeding or avoid treatment with sugammadex, taking into account the benefit of breast-feeding to the baby and the benefit of Sugammadex Amomed to the mother.

Driving and using machines

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

Sugammadex Amomed contains sodium

This medicine contains up to 9.4 mg of sodium (the main component of cooking/table salt) per ml. This is equivalent to 0.5% of the maximum recommended daily intake of sodium for an adult.

3. How Sugammadex Amomed is given

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

Dose

Your anaesthetist will calculate the dose of Sugammadex Amomed 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 adults and for children and adolescents from 2 to 17 years of age. A dose of 16 mg/kg can be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Amomed is given

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

If you are given more Sugammadex Amomed than recommended

Since your anaesthetist will be carefully monitoring the situation, it is unlikely that you will be given too much Sugammadex Amomed. 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, your anaesthetist will detect and treat them.

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

• Cough
• Respiratory difficulties that may include cough or movements as if you are awake or breathing
• 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 side effects (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 medicines), such as rash, skin redness, swelling of the tongue or pharynx, difficulty breathing, changes in blood pressure or heart rate, which sometimes results 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 the operation

Side effects with frequency not known

• When Sugammadex Amomed is given, 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, even if it is 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 Amomed

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 is the last day of the month shown.

Store below 30°C. 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.

6. Contents of the pack and other information

What Sugammadex Amomed contains

• The active substance is sugammadex.

Each ml of 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.

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

What Sugammadex Amomed looks like and contents of the pack

Sugammadex Amomed is a clear, slightly yellow solution for injection. It is available in packs of 10 vials of 2 ml solution for injection.

Marketing Authorisation Holder

AOP Orphan Pharmaceuticals GmbH

Leopold-Ungar-Platz 2

1190 Vienna

Austria

Manufacturer

Biofactor GmbH

Rudolf-Huch Straße 14

38667 Bad Harzburg

Germany

You can obtain further information on this medicine by contacting the local representative of the Marketing Authorisation Holder:

Date of last revision of this leaflet:

Other sources of information

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:

For detailed information, refer to the summary of product characteristics of Sugammadex Amomed.