SUGAMMADEX NORIDEM 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the Patient

Sugammadex Noridem 100 mg/ml Solution for Injection EFG

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 anesthesiologist (anesthetist) or your doctor.
• If you experience any side effects, talk to your anesthesiologist or another doctor, even if it is not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What is Sugammadex Noridem and what is it used for
2. What you need to know before you are given Sugammadex Noridem
3. How Sugammadex Noridem is given
4. Possible side effects
5. Storage of Sugammadex Noridem
6. Package Contents and Additional Information

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

What is Sugammadex Noridem

This medicine contains the active substance sugammadex. Sugammadex is considered a Selective Relaxant Binding Agent as it only works with specific muscle relaxants, namely rocuronium bromide or vecuronium bromide.

What Sugammadex Noridem is used for

If you need to have surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. To achieve this, you will be given medications during general anesthesia to relax your muscles. These are called muscle relaxants, such as rocuronium bromide and vecuronium bromide. Since these medications 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 and in children and adolescents (between 2 and 17 years) when rocuronium bromide is used for moderate muscle relaxation.

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

Do not receive Sugammadex Noridem

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

→ Tell your anesthesiologist if this applies to you.

Warnings and Precautions

Talk to your anesthesiologist before starting the administration of sugammadex

• if you have any kidney disease or have had it in the past. This is important because Sugammadex Noridem is eliminated from your body by the 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 coagulation disorders) or are taking anticoagulant medication.

Children and Adolescents

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

Other Medicines and Sugammadex Noridem

→ Tell your anesthesiologist 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 Noridem

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

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

Sugammadex Noridem May Affect Hormonal Contraceptives

• This medicine may make hormonal contraceptives - such as the "pill", vaginal ring, implants, or an Intrauterine Hormonal Device (IUD-h) - less effective because it reduces the amount of progestogen you receive. The amount of progestogen lost due to the use of sugammadex is approximately the same as that lost when you miss a contraceptive pill.

→ If you are taking the pillon the same day that you are given sugammadex, follow the instructions in case of a missed pill in the pill's package leaflet.

→ If you are using otherhormonal contraceptives (e.g., 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 leaflet.

Effects on Blood Tests

In general, Sugammadex Noridem 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 analyzed on the same day you receive this medicine.

Pregnancy and Breastfeeding

→ Tell your anesthesiologist if you are pregnant or might be pregnant or if you are breastfeeding.

It may still be given to you, but it needs to be discussed beforehand.

It is not known if sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to interrupt breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding to the baby and the benefit of sugammadex to the mother.

Driving and Using Machines

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

Sugammadex Noridem Contains Sodium

This medicine contains up to 9.19 mg of sodium (main component of cooking/table salt) per ml. This is equivalent to 0.46% of the maximum recommended daily sodium intake for an adult.

3. How Sugammadex Noridem is Given

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

Dose

Your anesthesiologist will calculate the dose of sugammadex 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 between 2-17 years. A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.

How Sugammadex Noridem is Given

This medicine will be administered by your anesthesiologist. It is injected once into a vein.

If you are given more Sugammadex Noridem than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much Sugammadex Noridem. But even if this happens, it is unlikely to cause any problems.

If you have any other questions about the use of this medicine, ask your anesthesiologist or another 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 anesthesia, it will be your anesthesiologist 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 anesthesia – you may start to wake up, so you may need more anesthesia. This can 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 medicines) - such as rash, skin redness, swelling of your tongue and/or pharynx, difficult 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 (cannot be estimated from the available data)

• When Sugammadex Noridem 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 anesthesiologist or another doctor, even if it is a possible side effect not listed in this leaflet. You can also report them directly through the Spanish Medicines Surveillance System for Human Use, www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Noridem

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.

This medicine does not require any special storage temperature. Keep the ampoule in the outer packaging to protect it from light.

After first opening and dilution, chemical and physical stability has been demonstrated for 48 hours between 2°C and 8°C and at 25°C at a sugammadex concentration of 10 mg/ml. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not exceed 24 hours between 2°C and 8°C, unless the dilution has been made in controlled and validated aseptic conditions.

6. Package Contents and Additional Information

Composition of Sugammadex Noridem

• The active substance is sugammadex.

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

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

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

• The other ingredients are water for injections, hydrochloric acid 3.65% w/v (for pH adjustment), and sodium hydroxide, solution 4.00% w/v (for pH adjustment).

Appearance and Package Contents

Sugammadex Noridem is a clear, colorless to slightly yellowish solution for injection.

Glass ampoules containing 2 ml or 5 ml of solution for injection, packaged in cardboard boxes.

Package size: 10 ampoules of 2 ml, 10 ampoules of 5 ml.

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Noridem Enterprises Ltd.

Evagorou & Makariou

Mitsi Building 3, Office 115

1065 Nicosia, Cyprus

Manufacturer

DEMO S.A. PHARMACEUTICAL INDUSTRY

21st Km National Road Athens-Lamia.

14568 Greece

This medicine is authorized in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Leaflet:November 2023

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) (http://www.aemps.gob.es/)

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This information is intended only for healthcare professionals:

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