Prospecto:information for the user

Sugammadex Qilu 100mg/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 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 Qilu is and for what it is used

2.What you need to knowbeforestarting the administration ofSugammadex Qilu

3.How Sugammadex Qilu is administered

4.Possible adverse effects

5Storage of Sugammadex Qilu

6.Contents of the package and additional information

What is Sugammadex Qilu

Sugammadex Qilu contains the active ingredient sugammadex. This medication is considered aSelective Agent for Blocker Bindingas it only works with specific muscle relaxants, namely bromide ofrocuronium or bromide of vecuronium.

What is Sugammadex Qilu used for

If you need to undergo surgery, your muscles must be completely relaxed, which facilitates the surgeon's operation. To do this, during general anesthesia, they will give you medications to relax your muscles. These are calledmuscle blockers, 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.

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 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 2and 17years), when bromide of rocuronium is used for a moderate level of relaxation.

You should not receive Sugammadex Qilu

• 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 before starting the administration of Sugammadex Qilu

• 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

This medication is not recommended for children under 2 years old.

Other medications and Sugammadex Qilu

Inform your anesthesiologist if you are taking, have taken recently, or may need to take

any other medication.

This medication may affect other medications or be affected by them.

Some medications reduce the effect ofSugammadex Qilu

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

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

Sugammadex Qilu may affect hormonal contraceptives

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

• If you are taking The Pill on the same day that you receive Sugammadex Qilu, follow the instructions in case of forgetting a pill from the contraceptive pill package insert.

instructions in case of forgetting a pill from the contraceptive pill package insert.

• If you are using other hormonal 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 recommendations from the package insert.

follow the recommendations from the package insert.

Effects on blood tests

In general, this medication does not have effects 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 Sugammadex Qilu.

Pregnancy and breastfeeding

Inform your anesthesiologist before receiving this medication if you are pregnant or breastfeeding, or if you think you may be pregnant or plan to become pregnant. It is possible that you will still receive this medication, but you need to discuss it first.

We do not know if sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to stop breastfeeding or avoid treatment with this medication, considering the benefit of breastfeeding for the baby and the benefit 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 Qilu contains sodium

This medication contains up to 9.7 mg of sodium (main component of table salt/for cooking) in each ml. This is equivalent to 0.5% of the maximum daily sodium intake recommended for an adult.

This medication will be administered to you by your anesthesiologist, or under the supervision of your anesthesiologist.

Dose

Your anesthesiologist will calculate the dose of Sugammadex that you need based on:

• your weight
• the amount of muscle relaxant that is still in effect.

The usual dose is 2-4mg per kg of body weight for adults and for children and adolescents between 2-17years. A dose of 16mg/kg may be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Qilu is Administered

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

If you are given more Sugammadex Qilu than recommended

Since your anesthesiologist will be closely monitoring the situation, it is unlikely that you will be given

too much Sugammadex Qilu. 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 cause side effects, although not everyone will experience them.

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

Frequent: that may affect up to 1in every 10people

• Cough
• 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 operation
• Complications during the procedure, such as changes in heart rate, coughing, or movement
• Decrease in blood pressure due to surgical intervention

Rare: that may affect up to 1in every 100people

• 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 a severe decrease in blood pressure. 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: cannot be estimated from available data

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

Reporting of side effects

If you experience any type of side effect, consult your anesthesiologist or another doctor, even if it is possible side effects that do not appear in this prospectus. You can also report them directly through theSpanish System of Pharmacovigilance of Medications for Human Use:www.notificaRAM.es.By reporting side effects, you can contribute to providing more information about the safety of this medication.

Storage will be handled by 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.

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

After the first opening and dilution, chemical and physical stability has been demonstrated for use within 48 hours between 2°C and 25°C. From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, storage times in use and conditions before use are the responsibility of the user and generally should not exceed 24 hours between 2°C and 8°C, unless the dilution was performed in controlled and validated aseptic conditions.

.Composition of Sugammadex Qilu

• The active ingredient is sugammadex.

Each milliliter of injectable solution contains sodium sugammadex equivalent to 100mg of sugammadex.

Each vial of 2ml contains sodium sugammadex equivalent to 200mg of sugammadex.

Each vial of 5ml contains sodium sugammadex equivalent to 500mg of sugammadex.

• The other components are hydrochloric acid 3.7% (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injectable preparations.

Appearance of the product and contents of the package

Sugammadex Qilu is a transparent, colorless to slightly yellowish injectable solution.

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

Only some package sizes may be commercially available.

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

PHARMAVIC IBERICA, S.L.

C/ Compositor Lehmberg Ruiz 6, Office 7

29007 Málaga

Spain

Phone: +34 951 008 628

This medicine is authorized in the member states of the European Economic Areawith the following names:

Last review date of thisleaflet:September 2022

Other sources of information

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

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This information is intended solely for healthcare professionals:

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