Sugammadex Qilu

Package leaflet: Information for the user

Sugammadex Qilu 100 mg/mL solution for injection

sugammadex
Generic medicine
Please read 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 questions, ask your anaesthetist or doctor.
• If you experience any side effects, including those not listed in this leaflet, tell your anaesthetist or doctor. 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 Sugammadex Qilu is administered
3. How Sugammadex Qilu is administered
4. Possible side effects
5. How to store Sugammadex Qilu
6. Contents of the pack and other information

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

What Sugammadex Qilu is
Sugammadex Qilu contains the active substance sugammadex. This medicine is considered to be a selective relaxant binding agent because it selectively binds to other medicines, rocuronium bromide or vecuronium bromide, known as muscle relaxants, which relax the muscles.

What Sugammadex Qilu is used for
During certain types of surgery, muscles need to be completely relaxed. This makes the surgeon's task easier. For this purpose, muscle-relaxing medicines are added to the general anaesthesia administered. These medicines are called muscle relaxants, and include rocuronium bromide and vecuronium bromide. Since these medicines also relax the muscles controlling breathing, breathing support (so-called artificial ventilation) is required during and after surgery, until you are able to breathe on your own again.

This medicine is used to speed up muscle recovery after surgery, allowing you to breathe independently again as soon as possible. It works by binding to rocuronium bromide or vecuronium bromide present in the 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 muscle relaxation.

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
Inform your anaesthetist before Sugammadex Qilu is administered

• if you currently have or have previously had kidney disease. This is important because sugammadex is eliminated from the body through the kidneys.
• if you currently have or have previously had liver disease.
• if you have fluid retention (oedema).
• if you have conditions known to increase the risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medicines.

Children
This medicine is not recommended for children under 2 years of age.
Other medicines and Sugammadex Qilu
Inform your anaesthetist if you are taking, have recently taken, or might take any other
medicine. This medicine may affect or be affected by other medicines.
Some medicines reduce the effect of Sugammadex Qilu
It is particularly 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 reduce the effectiveness of hormonal contraceptives (including oral contraceptive pill, vaginal ring, implant, or hormonal intrauterine system (IUS)), as it reduces the amount of absorbed progestogenic hormone. The amount of progestogen lost when Sugammadex Qilu is used is approximately equivalent to missing one dose of the contraceptive pill.

• If you are to take the oral contraceptive pill on the same day that Sugammadex Qilu is administered, follow the instructions in the contraceptive pill’s package leaflet regarding a missed dose.
• If you are using other hormonal contraceptives (e.g. a vaginal ring, implant, or IUS), you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the instructions provided in the product leaflet.

Effects on blood test results
In general, this medicine does not affect blood test results. However, it may interfere with the results of a blood test measuring levels of a hormone called progesterone.
Please consult your doctor if testing for progesterone levels is required on the same day you receive Sugammadex Qilu.
Pregnancy and breastfeeding
If you are pregnant, suspect you may be pregnant, planning a pregnancy, or are breastfeeding, please consult your anaesthetist before receiving this medicine.
You may still receive this medicine, but you should discuss it with your doctor first.
It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to discontinue breastfeeding or to avoid treatment with this medicine, taking into account the benefits of breastfeeding for the child 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 Qilu contains sodium
This medicine contains up to 9.7 mg of sodium (a main component of table salt) per mL.
This is equivalent to 0.5% of the maximum recommended daily dietary intake of sodium for an adult.

3. How Sugammadex Qilu is administered

This medicine will be administered to you by an anaesthetist or under the supervision of an anaesthetist.
The dose
The anaesthetist will determine the dose of sugammadex appropriate for you, taking into consideration:

• your body weight
• the extent to which the muscle relaxant is still acting on you.

The usual dose is 2–4 mg per kg of body weight in adults and in children and adolescents aged between 2 and 17 years. A dose of 16 mg/kg may be used in adults if rapid reversal of muscle relaxation is required.
How Sugammadex Qilu is administered
This medicine will be administered to you by the anaesthetist. It is given as a single intravenous injection.
If more Sugammadex Qilu is administered than intended
Since the anaesthetist will closely monitor your condition, it is unlikely that you will receive an excessive amount of Sugammadex Qilu. However, if this were to happen, it is unlikely to cause you any problems.
If you have any doubts about the use of this medicine, consult your anaesthetist or doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If such side effects occur during anaesthesia, they will be detected and treated by the anaesthetist.

Common: may affect up to 1 in 10 people

• Cough
• Breathing difficulties, which may include coughing or movements resembling waking up or gasping for breath
• Light anaesthesia – you may begin to come out of deep sleep and may therefore require additional anaesthetic. This could cause the patient to move or cough at the end of the procedure
• Complications during the procedure such as changes in heart rate, coughing or movements
• Decrease in blood pressure due to the surgical procedure

Uncommon: may affect up to 1 in 100 people

• In patients with a history of lung problems, shortness of breath due to muscle contractions of the airways (bronchospasm) has been observed
• Allergic reactions (hypersensitivity to the drug), such as skin rash, flushed skin, swelling of the tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, which sometimes may lead to severe drops in blood pressure. Severe allergic or anaphylactoid reactions can be life-threatening. Allergic reactions have been reported more frequently in healthy, conscious volunteers
• Return of muscle relaxation after surgery.

Not known: frequency cannot be estimated from the available data

• When Sugammadex Qilu is administered, severe slowing of the heart rate and slowing of the heart to the point of cardiac arrest may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your anaesthetist or doctor. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse.
Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Sugammadex Qilu

Storage will 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 that month.
Store below 30°C. Do not freeze. Keep the vial in the outer packaging to protect the medicine from light.
After first opening and dilution, chemical and physical in-use stability has been demonstrated for 48 hours at a temperature of 2–25°C. From a microbiological standpoint, the diluted product should be used immediately. If the product is not used immediately, the duration and conditions of storage prior to use are the responsibility of the user; normally, storage should not exceed 24 hours at 2–8°C, unless dilution has been carried out under controlled and validated aseptic conditions.

6. Package contents and other information

What Sugammadex Qilu contains

• The active substance is sugammadex. 1 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.

Description of the appearance of Sugammadex Qilu and contents of the pack
Sugammadex Qilu is a clear, colourless to pale yellow injectable solution.
It is available in two different pack sizes, containing either 10 vials with 2 mL of injectable solution or 10 vials with 5 mL of injectable solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation 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
WESSLING Hungary Kft.
Anonymus Utca 6, Budapest
H-1045,
Hungary

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Germany Sugammadex Qilu 100 mg/ml Injektionslösung
Denmark Sugammadex Qilu
Spain Sugammadex Qilu 100 mg/ml solución inyectable EFG
Finland Sugammadex Qilu 100 mg/ml injektioneste, liuos
France SUGAMMADEX QILU 100 mg/mL, solution injectable
Croatia Sugamadeks Qilu 100 mg/ml otopina za injekciju
Hungary Sugammadex Qilu 100 mg/ml oldatos injekció
Italy Sugammadex Qilu
Netherlands Sugammadex Qilu 100 mg/ml oplossing voor injectie
Norway Sugammadex Qilu
Sweden Sugammadex Qilu 100 mg/ml injektionsvätska, lösning
Slovenia Sugamadeks Qilu 100 mg/ml raztopina za injiciranje

The following information is intended exclusively for healthcare professionals:

For detailed information, refer to the product characteristics summary of Sugammadex
Qilu.