SUGAMMADEX PROVEPHARM 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Provepharm 100 mg/ml Solution for Injection

sugammadex

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 or another doctor.
• If you experience side effects, ask your anesthesiologist or another doctor, even if they are not listed in this leaflet. See section 4.

Contents of the Package Leaflet

1. What Sugammadex Provepharm 100 mg/ml Solution for Injection is and what it is used for
2. What you need to know before you are given Sugammadex Provepharm 100 mg/ml Solution for Injection
3. How Sugammadex Provepharm 100 mg/ml Solution for Injection is given
4. Possible side effects
5. Storage of Sugammadex Provepharm 100 mg/ml Solution for Injection
6. Contents of the pack and further information

1. What Sugammadex Provepharm 100 mg/ml Solution for Injection is and what it is used for

What Sugammadex Provepharm 100 mg/ml Solution for Injection is

Sugammadex Provepharm 100 mg/ml Solution for Injection contains the active substance sugammadex. Sugammadex is considered a selective relaxant binding agent because it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex Provepharm 100 mg/ml Solution for Injection 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 medicines during general anesthesia to relax your muscles.

These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these medicines 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 muscle recovery 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 relaxation.

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2. Before you are given Sugammadex Provepharm 100 mg/ml Solution for Injection

You should not be given Sugammadex Provepharm 100 mg/ml Solution for Injection

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

? Inform your anesthesiologist if this applies to you.

Warnings and Precautions

Talk to your anesthesiologist before you are given Sugammadex Provepharm 100 mg/ml Solution for Injection.

? if you have kidney disease or have had it in the past. This is important because Sugammadex Provepharm 100 mg/ml Solution for Injection 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 Provepharm 100 mg/ml Solution for Injection

Tell your anesthesiologist if you are taking, have recently taken, or might take any other medicines.

Sugammadex Provepharm 100 mg/ml Solution for Injection may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex Provepharm 100 mg/ml Solution for Injection. It is especially important that you inform your anesthesiologist if you have recently taken:

? toremifene (used to treat breast cancer).

? fusidic acid (an antibiotic).

Sugammadex Provepharm 100 mg/ml Solution for Injection 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 that reaches you. The amount of progestogen lost due to the use of Sugammadex Provepharm 100 mg/ml Solution for Injection is approximately the same as that lost when you miss a contraceptive pill.

? If you are taking the Pill on the same day that you are given Sugammadex Provepharm 100 mg/ml Solution for Injection, follow the instructions in case of a missed pill in the Pill's package leaflet.

? If you are using other hormonal 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 package leaflet.

Effects on Blood Tests

In general, Sugammadex Provepharm 100 mg/ml Solution for Injection 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 that you receive Sugammadex Provepharm 100 mg/ml Solution for Injection.

Pregnancy and Breastfeeding

Tell your anesthesiologist if you are pregnant or think you may be pregnant or if you are breastfeeding.

It is possible that you will still be given Sugammadex Provepharm 100 mg/ml Solution for Injection, 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 stop breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding for the baby and the benefit of Sugammadex Provepharm 100 mg/ml Solution for Injection for the mother.

Driving and Using Machines

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

Sugammadex Provepharm 100 mg/ml Solution for Injection contains sodium

This medicine contains up to 9.7 mg of sodium (a major component of cooking/table salt) per ml.

This is equivalent to 0.5% of the maximum recommended daily sodium intake for an adult.

3. How to use Provepharm Sugammadex 100 mg/ml Solution for Injection

Provepharm Sugammadex 100 mg/ml Solution for Injection will be given to you by your anesthesiologist or under their supervision.

Dose

Your anesthesiologist will calculate the dose of Provepharm Sugammadex 100 mg/ml Solution for Injection that 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 Provepharm 100 mg/ml Solution for Injection is given

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

If you are given more Sugammadex Provepharm 100 mg/ml Solution for Injection than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much Provepharm Sugammadex 100 mg/ml Solution for Injection. 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.

In case of overdose or accidental ingestion, consult the Toxicology Information Service, phone (91) 562 04 20.

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.

Frequent(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 intervention

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

? Significant slowing of the heart that can even lead to cardiac arrest

Reporting of Side Effects

If you experience any side effects, ask your anesthesiologist or another doctor, even if they are not listed in this leaflet. You can also report them directly through the Spanish Pharmacovigilance Center for Human Use Medicines: www.notificaRAM.es.

By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Provepharm 100 mg/ml Solution for Injection

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 label after “EXP”. The expiry date is the last day of the month stated.

Do not refrigerate or freeze. Keep the vial in the outer 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 / Further Information

Composition of Sugammadex Provepharm 100 mg/ml Solution for Injection

? 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 37%, and/or sodium hydroxide.

Appearance and Contents of the Pack

Provepharm Sugammadex 100 mg/ml Solution for Injection is a clear, colorless to slightly yellow solution for injection.

It comes in two different pack sizes, 1 or 10 vials of 2 ml and 1 or 10 vials of 5 ml of solution for injection.

Not all pack sizes may be marketed.

Marketing Authorization Holder

Provepharm

22 rue Marc Donadille

13013 Marseille

France

+00 33 (0)4 91 08 69 30

Manufacturer

Fisiopharma S.r.l.

Nucleo Industriale 8402 Palomonte (SA)

Italy

Date of Last Revision of this Leaflet: February 2023

This information is intended only for healthcare professionals:

For detailed information, consult the Summary of Product Characteristics or the Package Leaflet of Provepharm Sugammadex 100 mg/ml Solution for Injection.

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