Sugammadex Amomed 100 mg/ml solution for injection

Package leaflet: Information for the user

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, as you may need to read it again.
• If you have any questions, ask your anaesthetist (anaesthesiologist) or your doctor.
• If you experience any side effects, talk to your anaesthetist or another doctor, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

What Sugammadex Amomed is

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

What Sugammadex Amomed is used for

During surgery, your muscles need to be completely relaxed, which makes the procedure easier for the surgeon. For this reason, during general anaesthesia, you will be given medicines 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 assistance with breathing (mechanical ventilation) during and after surgery until you can breathe on your own again. Sugammadex Amomed is used to speed up muscle recovery after surgery so that you can 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 is used, and in children and adolescents (aged 2 to 17 years), when rocuronium bromide is used for moderate relaxation.

2. What you need to know before receiving Sugammadex Amomed

Do not receive Sugammadex Amomed

• if you are allergic to sugammadex or to any of the other ingredients 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 Amomed

• if you have kidney disease or have had it in the past. This is important because Sugammadex Amomed is eliminated from your body through the kidneys.
• if you have liver disease or have had it previously.
• if you have fluid retention (oedema).
• if you have a condition that increases your 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

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

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

Some medicines reduce the effect of Sugammadex Amomed

→ 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 Amomed may affect hormonal contraceptives

• Sugammadex Amomed may make hormonal contraceptives —such as the “pill”, vaginal ring, implants, or a hormonal intrauterine device (IUD-h) — less effective because it reduces the amount of progestogen hormone available to you. The amount of progestogen lost due to Sugammadex Amomed is approximately the same as when a contraceptive pill is missed.

→ If you take the Pill on the same day that Sugammadex Amomed is administered, follow the missed-dose 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 next 7 days and follow the recommendations in the contraceptive’s package leaflet.

Effects on blood tests

In general, Sugammadex Amomed has no effect 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 Amomed.

Pregnancy and breastfeeding

→ Inform your anaesthetist if you are pregnant, may be pregnant, or are breastfeeding.

You may still be given Sugammadex Amomed, but this should be discussed beforehand.

It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to discontinue breastfeeding or to avoid treatment with sugammadex, taking into account the benefits of breastfeeding for the baby and the benefits of Sugammadex Amomed for the mother.

Driving and using machines

Sugammadex Amomed has no known influence on the ability to drive or operate machinery.

Sugammadex Amomed contains sodium

This medicine contains up to 9.4 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 Amomed is administered

Sugammadex Amomed will be administered by your anaesthetist, or under the supervision of your anaesthetist.

Dosage

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

• your body weight
• the amount of residual muscle relaxant effect still present.

The usual dose is 2–4 mg per kg of body weight for adults and for children and adolescents aged 2–17 years. A dose of 16 mg/kg may be used in adults if rapid reversal of muscle relaxation is required.

How Sugammadex Amomed is administered

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

If you are given more Sugammadex Amomed than you should

Since your anaesthetist will be carefully monitoring your condition, it is unlikely that you will receive too much Sugammadex Amomed. However, even if this were to happen, 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 can cause adverse effects, although not everyone experiences them.

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

Frequent adverse effects (may affect up to 1 in 10 people)

• Cough
• Respiratory tract difficulties which may include coughing or movements as if awake or breathing
• Superficial anaesthesia – you may begin 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
• Decreased blood pressure due to the surgical intervention

Uncommon adverse effects (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 medicines), such as rash, skin redness, swelling of the tongue or pharynx, breathing difficulty, changes in blood pressure or heart rhythm, sometimes resulting in a severe drop in blood pressure. Allergy-type reactions or severe allergic reactions may be life-threatening

Allergic reactions were reported more frequently in healthy conscious volunteers

• Recurrence of muscle relaxation after surgery

Adverse effects of unknown frequency

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

Reporting of adverse effects

If you experience any type of adverse effect, 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 Amomed

Storage is 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 stated on the carton and label after "EXP".

The expiry date refers to the last day of the month indicated.

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

Composition of Sugammadex Amomed

• The active substance is sugammadex.

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

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

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

Appearance of Sugammadex Amomed and contents of the pack

Sugammadex Amomed is a slightly yellow, clear injectable solution. It is supplied in packs of 10 vials containing 2 ml of injectable solution each.

Marketing Authorization Holder

AOP Orphan Pharmaceuticals GmbH
Leopold-Ungar-Platz 2
1190 Vienna
Austria

Manufacturer responsible for manufacturing

Biofactor GmbH
Rudolf-Huch Straße 14
38667 Bad Harzburg
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

Other sources of information

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:

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