SUGAMMADEX SANDOZ 100 mg/ml INJECTABLE SOLUTION

Introduction

Leaflet: information for the user

Sugammadex Sandoz 100 mg/ml solution for injection EFG

Read all of this leaflet carefully before you start using 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 they are not listed in this leaflet. See section 4.

Contents of the leaflet

1. What is Sugammadex Sandoz and what is it used for
2. What you need to know before you start using Sugammadex Sandoz
3. How Sugammadex Sandoz is administered
4. Possible side effects
5. Storage of Sugammadex Sandoz
6. Contents of the pack and further information

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

What is Sugammadex Sandoz

This medicine 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 Sandoz is used for

If you need to have surgery, your muscles must be completely relaxed, which makes the operation easier for the surgeon. For 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 accelerate muscle recovery 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 start using Sugammadex Sandoz

Do not use Sugammadex Sandoz

• 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 you start using sugammadex

• if you have kidney disease or have had it in the past. This is important because sugammadex is eliminated from your body by the kidneys.
• if you have liver disease or have had it before.
• if you have fluid retention (edema).
• 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 Sandoz

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

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 may affect hormonal contraceptives

Sugammadex 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 that reaches you. The amount of progestogen lost due to the use of sugammadex is approximately the same as that lost when you forget one of the contraceptive pills.

→ 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 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 leaflet.

Effects on blood tests

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

Pregnancy and breastfeeding

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

You may still be given sugammadex, but it needs to be discussed beforehand.

It is not known whether 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 for the baby and the benefit of sugammadex for the mother.

Driving and using machines

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

Sugammadex Sandoz contains sodium

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

The 2 ml vial contains less than 23 mg of sodium, which is essentially "sodium-free".

The 5 ml vial contains up to 48.5 mg of sodium (the main component of table/cooking salt) per ml. This is equivalent to 2.5% of the maximum recommended daily sodium intake for an adult.

3. How Sugammadex Sandoz is administered

Sugammadex will be administered to you by your anesthesiologist or under their supervision.

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 of muscle relaxation is needed.

How Sugammadex Sandoz is administered

Sugammadex will be administered to you by your anesthesiologist. It is injected once into a vein.

If you are given too much Sugammadex Sandoz

Since your anesthesiologist 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.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount ingested.

If you have any further 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, your anesthesiologist will detect and treat them.

Common (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if you were awake or taking a breath
• Light anesthesia - you may start to wake up, so you may need more anesthetic. 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 can sometimes result in a severe drop in blood pressure. 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 anesthesiologist or another doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance System for Human Use Medicines: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Sandoz

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 after CAD/EXP. The expiry date is the last day of the month shown.

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

After first opening

After first opening, the physical and chemical stability in use has been demonstrated for 96 hours at 2 °C-8 °C protected from light and at 20 °C-25 °C without protection from light (removal of the solution with a needle or with an injection spike).

Additionally, the solution for injection, removed as described above, is chemically and physically stable in polypropylene syringes for 96 hours at 2 °C-8 °C with protection from light and at 20 °C-25 °C without protection from light.

From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the storage times and conditions before use are the responsibility of the user and should not normally exceed 24 hours between 2 °C and 8 °C, unless the dilution has been made in controlled and validated aseptic conditions

After dilution

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

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 further information

Composition of Sugammadex Sandoz

• 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.

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

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

Appearance and packaging

Sugammadex is a solution for injection. It is a clear, colorless to slightly yellow-brown solution, practically free of visible particles, in a type I colorless glass vial with a gray rubber stopper.

It is available in three different pack sizes, 10 vials of 2 ml or 1 or 10 vials of 5 ml of solution for injection.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Sandoz Farmacéutica, S.A.

Centro Empresarial Parque Norte

Edificio Roble

C/ Serrano Galvache, 56

28033 Madrid

Spain

Manufacturer

Lek Pharmaceuticals, d.d.

Verovškova 57,

SLO-1526 Ljubljana

Slovenia

This medicine is authorized in the Member States of the European Economic Area and the United Kingdom (Northern Ireland) under the following names:

Date of last revision of this leaflet:December 2022

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

--------------------------------------------------------------------------------------------------------------------

This information is intended only for healthcare professionals.

For detailed information, consult the Summary of Product Characteristics or the Package Leaflet of Sugammadex Sandoz 100 mg/ml solution for injection EFG.