SUGAMMADEX VIVANTA 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Vivanta 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 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 Package Leaflet

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

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

What is Sugammadex Vivanta

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

What Sugammadex Vivanta is used for

If you need to undergo surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. 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 the recovery of your muscles 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 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 Vivanta

You must not be given Sugammadex Vivanta

• 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 treatment with this medicine:

• 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 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 Vivanta

→ 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 Vivanta

→ 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 Vivanta may affect hormonal contraceptives

• This medicine 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 you receive. The amount of progestogen lost due to the use of this medicine is approximately the same as when you miss a contraceptive pill.

→ If you are taking the Pillon the same day you are given this medicine, 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), 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 you receive this medicine.

Pregnancy and breastfeeding

→ If you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant, talk to your anesthesiologist before using this medicine. You may still be given this medicine, 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 this medicine to the mother.

Driving and using machines

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

Sugammadex Vivanta contains sodium

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

3. How Sugammadex Vivanta 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 children and adolescents from 2 to 17 years. A dose of 16 mg/kg can be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Vivanta is administered

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

If you are given more Sugammadex Vivanta than recommended

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.

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 waking up 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 the surgical procedure.

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

• 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 Vivanta

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 stated.

This medicine does not require any special storage temperature.

Keep the vial in the original packaging to protect it from light.

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

6. Contents of the pack and further information

Composition of Sugammadex Vivanta

• 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, 0.36% hydrochloric acid, and/or 0.4% sodium hydroxide.

Appearance of Sugammadex Vivanta and contents of the pack

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

It comes in two different pack sizes, each containing 10 vials of 2 ml 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

Vivanta Generics s.r.o.

Trtinová 260/1, Cakovice

196 00 Prague 9,

Czech Republic

Manufacturer

Pharmadox Healthcare Limited,

KW20A Kordin Industrial Park, Paola, PLA3000,

Malta

Or

MSN Labs Europe Limited,

KW20A Corradino Park, Paola, PLA3000,

Malta

You can request more information about this medicine by contacting the local representative of the marketing authorization holder:

Local Representative:

Vivanta Generics s.r.o., Spanish branch

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

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

Member StatesMedicine names

Germany Sugammadex Vivanta 100 mg/ml Injektionslösung

Spain Sugammadex Vivanta 100 mg/ml solution for injection EFG

Netherlands Sugammadex Vivanta 100 mg/ml, oplossing voor injectie

Cyprus Sugammadex MSN 100 mg/ml, solution for injection

Ireland Sugammadex 100 mg/mL solution for injection

Date of last revision of this leaflet: May 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 Vivanta.