Sugammadex Vivanta 100 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Sugammadex Vivanta 100 mg/ml solution for injection EFG

Read the entire 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, consult your anaesthetist (anaesthesiologist) or your doctor.
• If you experience any adverse reactions, consult your anaesthetist or another doctor, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

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

What Sugammadex Vivanta is

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

What Sugammadex Vivanta is used for

If you need surgery, your muscles must be completely relaxed, which makes the surgical 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, such as 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 your surgery until you can breathe on your own again.

Sugammadex is used to speed up muscle recovery after surgery so that you can breathe on your own 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 levels of relaxation.

2. What you need to know before starting administration of Sugammadex Vivanta

Do not receive Sugammadex Vivanta

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

→ Inform your anaesthetist if this applies to you.

Warnings and precautions

Talk to your anaesthetist before starting administration of this medicine:

• if you have any kidney disease or have had it in the past. This is important because sugammadex is eliminated from your body through the kidneys.
• if you have liver disease or have had it previously.
• if you have fluid retention (edema).
• if you have any condition 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 Vivanta

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

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

Some medicines reduce the effect of Sugammadex Vivanta

→ 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 Vivanta may affect hormonal contraceptives

• This medicine may reduce the effectiveness of hormonal contraceptives—such as "the Pill", vaginal ring, implants, or a hormonal intrauterine device (IUD-h)—because it reduces the amount of progestogen hormone available to you. The amount of progestogen lost due to this medicine is approximately the same as when you miss one of your contraceptive pills.

→ If you are taking the Pill on the same day this medicine is administered, follow the missed-dose instructions provided in the contraceptive pill leaflet.

→ If you are using other hormonal contraceptives (e.g., vaginal ring, implant, or
IUD-h), you should use a non-hormonal complementary contraceptive method (such as a condom) for the following 7 days and follow the recommendations in the product leaflet.

Effects on blood tests

In general, sugammadex has no effects on laboratory tests. However, it may affect the results of a blood test when measuring levels of the hormone progesterone. Consult your doctor if progesterone levels need to be tested on the same day you receive this medicine.

Pregnancy and breastfeeding

→ If you are pregnant or breastfeeding, think you might be pregnant, or plan to become pregnant, consult your anaesthetist before using this medicine. You may still be given this medicine, but this should be discussed beforehand.

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

Driving and using machines

This medicine has no known influence on the ability to drive or operate machinery.

Sugammadex Vivanta contains sodium

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

3. How Sugammadex Vivanta is administered

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

Dosage

Your anesthesiologist will calculate the dose of sugammadex you require 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 children and adolescents aged 2 to 17 years. A dose of 16 mg/kg may be used in adults when rapid reversal of neuromuscular blockade is required.

How Sugammadex Vivanta is administered

This medicine will be administered by your anesthesiologist. It is given as a single intravenous injection.

If you are given more Sugammadex Vivanta than recommended

Since your anesthesiologist will be carefully monitoring your condition, it is unlikely that you will receive too much sugammadex. However, even if this were to occur, 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 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 anesthesia, your anaesthetist will detect and treat them.

Frequent (may affect up to 1 in 10 people)

• Cough.
• Airway difficulties that may include coughing or movements as if awake or gasping for breath.
• 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 procedure.

Uncommon (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, redness of the skin, swelling of the tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rhythm, which sometimes result in a severe drop in blood pressure. Allergy-type reactions or severe allergic reactions can be life-threatening.

Allergic reactions were reported more frequently in healthy conscious volunteers.

• Recurrence of muscle relaxation after surgery.

Frequency not known

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

Reporting of adverse effects

If you experience any adverse effects, 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 Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Vivanta

Storage shall 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 stated on the carton and label after “EXP”. The expiry date refers to the last day of the month indicated.

This medicine does not require any special storage temperature.

Store the vial in the original 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 Vivanta

• 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.

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

• The other components 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, colourless to slightly yellow injectable solution.

It is available in two different pack sizes, containing either 10 vials of 2 ml or 10 vials of 5 ml of injectable solution.

Only certain 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

For further information about this medicinal product, please contact 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, Spain

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

Member States Medicinal Product 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 latest revision of this leaflet: May 2023

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

This information is intended for healthcare professionals only:

For detailed information, refer to the Summary of Product Characteristics or the Technical Data Sheet of Sugammadex Vivanta.