Prospecto: information for the user

Sugammadex Amomed 100 mg/ml injectable solution

sugammadex

Read this prospect carefully before this medicine is administered to you, because it contains important information for you.

• Keep this prospect, as you may need to read it again.
• If you have any questions, consult your anesthesiologist (anesthetist) or doctor.
• If you experience any adverse effects, consult your anesthesiologist or another doctor, even if they are not listed in this prospect.

if they are not listed in this prospect. See section 4.

What is Sugammadex Amomed

Sugammadex Amomed contains the active ingredient sugammadex. Sugammadex Amomed is considered a selective neuromuscular blocker as it only works with specific muscle relaxants, namely rocuronium bromide or vecuronium bromide.

What is Sugammadex Amomed used for

If you are to undergo surgery, your muscles must be completely relaxed, which facilitates the surgeon's operation. For this, during general anesthesia, they will administer medications to relax your muscles. These are called neuromuscular blockers, and some examples are rocuronium bromide and vecuronium bromide. As these medications also block the muscles of respiration, you will need assistance with breathing (mechanical ventilation) during and after your operation until you can breathe on your own again. Sugammadex Amomed is used to accelerate muscle recovery after surgery so that you can breathe on your own again sooner. It does this by combining with rocuronium bromide or vecuronium bromide in your body. It can be used in adults as long as rocuronium bromide or vecuronium bromide is used, and in children and adolescents (between 2 and 17 years of age), when rocuronium bromide is used for moderate relaxation.

Do not receive Sugammadex Amomed

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

→Inform your anesthesiologist if this is the case.

Warnings and precautions

Consult your anesthesiologist beforestarting the administration of Sugammadex Amomed

• if you have any kidney disease or have had it in the past. This is important because Sugammadex Amomed is eliminated from your body by your kidneys.
• if you have liver disease or have had it previously.

if you have fluid retention (edema).

• if you have a disease that increases the risk of bleeding (blood clotting disorders) or are taking anticoagulant medication.

Children and adolescents

This medication is notrecommended for children under 2 years of age.

Other medications and Sugammadex Amomed

→Inform your anesthesiologist if you are taking, have taken recently, or may need to take any

other medication.

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

Some medications reduce the effect of Sugammadex Amomed

→It is especially important to inform your anesthesiologist if you have taken recently:

• toremifeno (used to treat breast cancer).
• acid fusídico (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 progestin hormone that reaches you. The amount of progestin hormone lost due to the use of Sugammadex Amomed is approximately the same as that lost when you forget a contraceptive pill.

→If you are taking the Pill on the same day that you receive Sugammadex Amomed, follow the instructions in the Pill package insert in case of missing a pill.

→If you are using other hormonal contraceptives (for example, vaginal ring, implant, or IUD-h), you should use a non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the package insert.

Effects on blood tests

In general, Sugammadex Amomed has no effects on analytical tests. However, it may affect the results of a blood test whenmeasuring progesterone hormone levels. Consult your doctor if your progesterone levels need to be analyzed on the same day you receive Sugammadex Amomed.

Pregnancy and breastfeeding

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

It may still be administered to you, but it is necessary to discuss it beforehand.

No information is available on whether sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding for the baby and the benefit of Sugammadex Amomed for the mother.

Driving and operating machinery

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

Sugammadex Amomed contains sodium

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

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

Dose

Your anesthesiologist will calculate the dose of Sugammadex Amomed needed based on:

• your weight
• the amount of muscle relaxant still in effect.

The usual dose is 2-4 mg per kg of body weight for adults and for children and adolescents between 2-17 years of age. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Amomed is Administered

Sugammadex Amomed will be administered by your anesthesiologist. It is injected once via intravenous route.

If more Sugammadex Amomed is Injected than Recommended

As your anesthesiologist will be closely monitoring the situation, it is unlikely that too much Sugammadex Amomed will be administered. Even if this happens, it is unlikely to cause any problems.

If you have any other questions about the use of this medication, ask your anesthesiologist or another doctor.

Like all medications, this medication may produce adverse effects, although not all people will experience them.

If these adverse effects occur while you are under the effects of anesthesia, your anesthesiologist will detect and treat them.

Frequent Adverse Effects (which may affect up to 1 in 10 people)

• Coughing
• Respiratory difficulties that may include coughing or movements as if you were awake or breathing
• Superficial anesthesia – you may start to wake up, so you will need more anesthetic. 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 surgical intervention

Rare Adverse Effects (which may affect up to 1 in 100 people)

• Difficulty breathing due to muscle cramps in the airways (bronchospasm) that occur in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medications), such as rash, redness of the skin, swelling of the tongue or pharynx, difficulty breathing, changes in blood pressure or heart rate, which sometimes results in severe decreased blood pressure. Severe allergic reactions or anaphylactic reactions can be life-threatening
• Allergic reactions were reported more frequently in healthy, conscious volunteers
• Reappearance of muscle relaxation after the operation

Adverse Effects of Unknown Frequency

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

Reporting Adverse Effects

If you experience any type of adverse effect, consult your anesthesiologist or another doctor, even if it is a possible adverse effect not listed in this prospectus. You can also report them directly through the national notification system included in theAppendix V. By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Conservation will be handled by healthcare professionals.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and on the label after “CAD”.

The expiration date is the last day of the month indicated.

Store below 30 °C. Do not freeze. Store the vial in the outer packaging to protect it from light.

Once opened and diluted, store at 2-8 °C and use within 24 hours.

Composition of Sugammadex Amomed

• The active ingredient is sugammadex.

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

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

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

Appearance of Sugammadex Amomed and contents of the package

Sugammadex Amomed is a transparent slightly yellowish injectable solution. It is presented in 10 vials of 2 ml injectable solution.

Marketing Authorization Holder

AOP Orphan Pharmaceuticals GmbH

Leopold-Ungar-Platz 2

1190 Vienna

Austria

Responsible Person

Biofactor GmbH

Rudolf-Huch Straße 14

38667 Bad Harzburg

Germany

For more information about this medicine, please contact the local representative of the marketing authorization holder:

Last review date of this leaflet:

Other sources of information

The detailed information on this medicine is available on the website of the European Medicines Agency:http://www.ema.europa.eu.

This information is intended solely for healthcare professionals:

For detailed information, please consult the summary of product characteristics of Sugammadex Amomed.