Sugammadex Qilu 100 mg/ml solution for injection EFG

Package Leaflet: Information for the user

Introduction

Package Leaflet: Information for the user

Sugammadex Qilu 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, as you may need to read it again.
• If you have any questions, ask your anaesthetist (anaesthesiologist) or your doctor.
• If you experience any side effects, talk to your anaesthetist or another doctor, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

What is Sugammadex Qilu

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

What is Sugammadex Qilu used for

If you are undergoing surgery, your muscles need to be completely relaxed, which makes it easier for the surgeon to perform the procedure. For this reason, during general anesthesia you will be given medications to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these medications also block the muscles involved in breathing, you will need assistance to breathe (mechanical ventilation) during and after your surgery until you are able to breathe on your own again.

This medicine is used to speed up muscle recovery after surgery so that you can breathe independently 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.

It can also be used in newborns, infants, children, and adolescents (from birth up to 17 years of age) when rocuronium bromide is used.

2. What you need to know before Sugammadex Qilu is administered

Do not receive Sugammadex Qilu

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

Inform your anaesthetist if this applies to you.

Warnings and precautions

Talk to your anaesthetist before Sugammadex Qilu is administered if:

• you have kidney disease or have had it in the past. This is important because
  Sugammadex is eliminated from your body through the kidneys.

• you have liver disease or have had it previously.

• you have fluid retention (oedema).

• you have a medical condition that increases your risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

Other medicines and Sugammadex Qilu

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

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

Some medicines reduce the effect of Sugammadex Qilu

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 Qilu may affect hormonal contraceptives

This medicine may make hormonal contraceptives – such as the "Pill", vaginal ring, implants, or a hormonal intrauterine device (IUD-h) – less effective because it reduces the amount of progestogen hormone available to you. The amount of progestogen lost due to the use of Sugammadex Qilu is approximately the same as when you miss one of your contraceptive pills.

• If you are taking the Pill on the same day that Sugammadex Qilu is administered, follow the instructions for missed dose as described in the leaflet of your contraceptive pill.

• If you are using other hormonal contraceptives (e.g. vaginal ring, implant, or IUD-h), you should use an additional 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 have any effect on laboratory tests. However, it may affect the results of a blood test when measuring levels of the hormone progesterone. Consult your doctor if your progesterone levels need to be tested on the same day you receive Sugammadex Qilu.

Pregnancy and breastfeeding

Inform your anaesthetist before receiving this medicine if you are pregnant or breastfeeding, if you think you might be pregnant, or if you plan to become pregnant. You may still be given this medicine, but you need to discuss it beforehand.

It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to stop breastfeeding or to avoid treatment with this medicine, 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 use machines.

Sugammadex Qilu contains sodium

This medicine contains up to 9.7 mg of sodium (the main component of table/cooking salt) per ml. This corresponds to 0.5% of the maximum daily recommended intake of sodium for an adult.

3. How Sugammadex Qilu is administered

This medicine will be administered to you by your anaesthetist, or under the supervision of your anaesthetist.

Dosage

Your anaesthetist will calculate the dose of Sugammadex you need 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 patients of any age. A dose of 16 mg/kg may be used in adults if urgent reversal of muscle relaxation is required.

How Sugammadex Qilu is administered

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

If you are given more Sugammadex Qilu than you should

Since your anaesthetist will be carefully monitoring your condition, it is unlikely that you will be given too much Sugammadex Qilu. However, even if this were to happen, it is unlikely to cause any problems.

If you have any further questions about the use of this medicine, ask your anaesthetist 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 anaesthesia, they will be detected and treated by your anaesthetist.

Frequent: may affect up to 1 in 10 people

• Cough
• Respiratory difficulties which may include coughing or movements resembling waking up or gasping for breath
• Superficial anaesthesia – you may begin to wake up, so you will require 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 intervention

Uncommon: may affect up to 1 in 100 people

• Breathing difficulty due to muscle spasms in the airways (bronchospasm), occurring in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medicines) – such as rash, skin redness, 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 may be life-threatening.

Allergic reactions were reported more frequently in healthy conscious volunteers.

• Recurrence of muscle relaxation after surgery

Not known: cannot be estimated from available data

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

Reporting of adverse effects

If you experience any type of adverse effect, consult your anaesthetist or another doctor, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Qilu

Storage must be managed by 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.

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 in-use stability has been demonstrated for 48 hours between 2°C and 25°C. From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and, in general, should not exceed 24 hours between 2°C and 8°C, unless the dilution has been carried out under controlled and validated aseptic conditions.

6. Contents of the container and other information

.Composition of Sugammadex Qilu

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

Appearance of the medicinal product and contents of the container

Sugammadex Qilu is a clear, colourless to slightly yellow, injectable solution.

It is available in two different pack sizes: 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

QILU PHARMA SPAIN S.L.

Paseo de la Castellana 40,

8th floor, 28046 - Madrid

Spain

Manufacturer

KYMOS, S.L.

Ronda de Can Fatjó,

7B (Parc Tecnològic del Vallès),

Cerdanyola del Vallès,

08290 Barcelona,

Spain

Local representative

Sun Pharma Laboratorios, S.L.

Rambla de Catalunya, 53-55

08007 – Barcelona

Spain

Tel.: +34 93 342 78 90

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

Date of the last revision of this leaflet: January 2026

Other sources of information

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

This information is intended for healthcare professionals only:

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