SUGAMMADEX QILU 100 mg/mL Injectable Solution

Introduction

Package Leaflet:information for the user

Sugammadex Qilu 100mg/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 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 pack

1. What Sugammadex Qilu is and what it is used for
2. What you need to know before you are given Sugammadex Qilu
3. How Sugammadex Qilu is given
4. Possible side effects

5 Storage of Sugammadex Qilu

1. Package contents and additional information

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

What Sugammadex Qilu is

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

What Sugammadex Qilu is used for

If you need to have 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 breathing muscles, you will need help breathing (artificial respiration) during and after surgery until you can breathe on your own again.

This medication 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 muscle relaxation.

2. What you need to know before you are given Sugammadex Qilu

You should not be given Sugammadex Qilu

• 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 are given Sugammadex Qilu

• 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 are taking anticoagulant medication.

Children

This medicine is not recommended for children under 2 years of age.

Other medicines and Sugammadex Qilu

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

This medicine may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex Qilu

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

• toremifene (used to treat breast cancer).
• fusidic acid (an antibiotic).

Sugammadex Qilu may affect hormonal contraceptives

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

• If you are taking the Pill on the same day you are given Sugammadex Qilu, follow the instructions in case of a missed pill in the Pill leaflet.

• If you are using other hormonal 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, this medicine 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 Sugammadex Qilu.

Pregnancy and breastfeeding

Tell your anesthesiologist before you are given this medicine if you are pregnant or breastfeeding, think you may be pregnant, or plan to become pregnant. You may still be given this medicine, but you need to discuss it first.

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 this medicine, 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 effects on the ability to drive or use machines.

Sugammadex Qilu contains sodium

This medicine contains up to 9.7 mg of sodium (main 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 Sugammadex Qilu is given

This medicine will be given 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 may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Qilu 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 Qilu than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much Sugammadex Qilu. 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 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 can be life-threatening.

Allergic reactions were reported more frequently in healthy conscious volunteers

• Reappearance of muscle relaxation after surgery

Rare: cannot be estimated from the available data

• When Sugammadex Qilu 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 Medicines Monitoring System: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Qilu

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.

Store below 30°C. Do not freeze. Keep the vial in the outer packaging to protect it from light.

After first opening and dilution, chemical and physical stability 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 in-use storage times and conditions are the responsibility of the user and should generally not exceed 24 hours between 2°C and 8°C, unless the dilution has been made under controlled and validated aseptic conditions.

6. Package contents and additional information

Composition of Sugammadex Qilu

• 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 hydrochloric acid 3.7% (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

Appearance and package contents

Sugammadex Qilu is a clear, colorless to slightly yellow solution for injection.

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

Not all package sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, 28046 - Madrid

Spain

Manufacturer

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parque Tecnológico del Vallès),

Cerdanyola del Vallès,

08290 Barcelona,

Spain

Or

Eurofins Analytical Services Hungary Kft.

Anonymus utca 6, Budapest

H-1045,

Hungary

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 – Barcelona

Spain

Tel.: +34 93 342 78 90

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

Date of last revision of this leaflet:September 2022

Other sources of information

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