Prospecto: information for the user

Sugammadex Vivanta 100 mg/ml injectable solution EFG

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 doubts, consult your anesthesiologist (anesthetist) or your doctor.
• If you experience adverse effects, consult your anesthesiologist or another doctor, even if they are not listed in this prospect. See section 4.

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

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

3. How Sugammadex Vivanta is administered

4. Possible adverse effects

5. Storage of Sugammadex Vivanta

6. Contents of the package and additional information

What is Sugammadex Vivanta

This medication contains the active ingredient sugammadex. Sugammadex is considered aSelective Relaxant Binding Agentas it only works with specific muscle relaxants, bromide of rocuronium or bromide of vecuronium.

What is Sugammadex Vivanta used for

If you need to undergo surgery, your muscles must be completely relaxed, which facilitates the surgeon's operation. For this, during general anesthesia, they will give you medications to relax your muscles. They are calledmuscle relaxants, and for example, bromide of rocuronium and bromide of vecuronium are examples. As these medications also block the muscles of respiration, you will need help breathing (artificial respiration) during and after your operation until you can breathe on your own again.

Sugammadex is used to accelerate muscle recovery after surgery so that, again, you can breathe on your own sooner. It does this by combining with bromide of rocuronium or bromide of vecuronium in your body. It can be used in adults as long as bromide of rocuronium or bromide of vecuronium is used and in children and adolescents (between 2 and 17 years), when bromide of rocuronium is used for a moderate level of relaxation.

Do not receive Sugammadex Vivanta

• 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 this medication:

• If you have any 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 clotting disorders) or are taking anticoagulant medication.

Children and adolescents

This medication is not recommended for children under 2 years.

Other medications and Sugammadex Vivanta

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

Sugammadex may affect other medications or be affected by them.

Some medications reduce the effect of Sugammadex Vivanta

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

• Toremifeno (used to treat breast cancer).
• Fusidic acid (an antibiotic).

Sugammadex Vivanta may affect hormonal contraceptives

• This medication may make hormonal contraceptives - such as "The Pill", vaginal ring, implants, or an Intrauterine Device (IUD-h) less effective because it reduces the amount of progesterone hormone that reaches you. The amount of progesterone lost as a result of using this medication is approximately the same as when you forget a contraceptive pill.

→ If you are takingThe Pillon the same day that this medication is administered, follow the instructions in case of missing a pill from the pill package.

→If you are usingotherhormonal contraceptives (such as 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 package instructions.

Effects on blood tests

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

Pregnancy and breastfeeding

→ If you are pregnant or breastfeeding, or think you may be pregnant, consult your anesthesiologist before using this medication. It is possible that you will still be given this medication, but it needs to be discussed 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 benefits of breastfeeding for the baby and the benefits of this medication for the mother.

Driving and operating machinery

This medication has no known influence on the ability to drive and operate machinery.

Sugammadex Vivanta contains sodium

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

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

Dose

Your anesthesiologist will calculate the dose of sugammadex 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 children and adolescents aged 2 to 17 years. A dose of 16 mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Vivanta is Administered

This medication will be administered by your anesthesiologist. It is injected once via intravenous route.

If You Receive More Sugammadex Vivanta than Recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that you will receive too much sugammadex. 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 may experience them.

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

Frequent (may affect up to 1 in 10 people)

• Coughing.
• Respiratory difficulties that may include coughing or movements as if you were awake or taking a breath.
• 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 procedure.
• Complications during the procedure, such as changes in heart rate, coughing, or movement.
• Decreased blood pressure due to surgical intervention.

Rare (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, skin redness, swelling of your tongue and/or pharynx, difficult breathing, changes in blood pressure or heart rate, which sometimes results in severe blood pressure drop. 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.

Unknown frequency

• When sugammadex 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 Spanish System of Pharmacovigilance for Medications for Human Use: https://www.notificaram.es.By reporting adverse effects, you can contribute to providing more information about the safety of this medication.

Conservation will be the responsibility of 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.

This medication does not require any special conservation temperature.

Store 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.

Sugammadex Vivanta Composition

• The active ingredient is sugammadex.

Each milliliter 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 injectable water, hydrochloric acid 0.36%, and/or sodium hydroxide 0.4%.

Appearance of Sugammadex Vivanta and packaging contents

Sugammadex Vivanta is a transparent, colorless to slightly yellow (injectable) solution.

It is presented in two different packaging sizes, containing 10 vials with 2 ml or 10 vials with 5 ml of injectable solution.

Only some packaging sizes may be commercially available.

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 medication by contacting the local representative of the marketing authorization holder:

Local Representative:

Vivanta Generics s.r.o. subsidiary in Spain

C/Guzmán el Bueno, 133, edificio Britannia

28003 Madrid

This medication is authorized in the European Economic Area member states with the following names:

Member statesMedication names

GermanySugammadex Vivanta 100 mg/ml Injektionslösung

SpainSugammadex Vivanta 100 mg/ml solución inyectable EFG

NetherlandsSugammadex Vivanta 100 mg/ml, oplossing voor injectie

CyprusSugammadex MSN 100 mg/ml, solution for injection

IrelandSugammadex 100 mg/mL solution for injection

Last review date of this leaflet: May 2023

More detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS)http://www.aemps.gob.es/

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This information is intended solely for healthcare professionals:

For detailed information, consult the Technical Dossier or the Product Characteristics Summary of Sugammadex Vivanta.