Sugammadex Aptapharma

Package Leaflet: Information for the Patient

Sugammadex AptaPharma, 100 mg/mL, Solution for Injection

Sugammadex

Read the package leaflet carefully before the medicine is given, as it contains important information for the patient.

• 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 any side effects, including those not listed in this leaflet, tell your anesthesiologist or another doctor. See section 4.

Table of Contents of the Package Leaflet

• 1. What is Sugammadex AptaPharma and what is it used for
• 2. Important information before taking Sugammadex AptaPharma
• 3. How is the medicine administered
• 4. Possible side effects
• 5. How to store Sugammadex AptaPharma
• 6. Contents of the pack and other information

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

Sugammadex AptaPharma contains the active substance sugammadex. Sugammadex AptaPharma is considered a selective relaxant binding agentbecause it only acts on certain muscle relaxants - rocuronium bromide or vecuronium bromide.

What is Sugammadex AptaPharma used for

In some types of surgery, the patient's muscles must be completely relaxed. This allows the surgeon to perform the operation more easily. To achieve this, muscle relaxants are administered during general anesthesia. These are called muscle relaxantsand include rocuronium bromide and vecuronium bromide. Since these medicines also cause relaxation of the respiratory muscles, assisted breathing (artificial ventilation) is necessary during and after the operation until the patient's own breathing returns. Sugammadex AptaPharma is used to accelerate the recovery of muscles after surgery, so that the patient can breathe on their own again sooner. Its action involves binding to rocuronium bromide or vecuronium bromide in the body. The medicine can be used in adults when rocuronium bromide or vecuronium bromide has been administered, as well as in children and adolescents (from 2 to 17 years old) when rocuronium bromide has been administered for moderate muscle relaxation.

2. Important information before taking Sugammadex AptaPharma

When not to use Sugammadex AptaPharma

Warnings and precautions

Before taking Sugammadex AptaPharma, discuss with your anesthesiologist:

Children and adolescents

It is not recommended to use this medicine in infants under 2 years of age.

Sugammadex AptaPharma and other medicines

Tell your anesthesiologist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Sugammadex AptaPharma may affect the action of other medicines, or other medicines may affect the action of Sugammadex AptaPharma.

Some medicines reduce the effectiveness of Sugammadex AptaPharma

It is especially important to inform your anesthesiologist if the patient has recently taken the following medicines:

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

Sugammadex AptaPharma may affect the effectiveness of hormonal contraceptives

• Sugammadex AptaPharma may reduce the effectiveness of hormonal contraceptives, including "the pill", vaginal ring, implant, or intrauterine system releasing progestogen, as it reduces the amount of hormone delivered. The amount of progestogen lost due to the use of Sugammadex AptaPharma is roughly equivalent to missing one contraceptive pill. If the patient is taking "the pill" on the same day that Sugammadex AptaPharma is administered, follow the instructions for missing a pill in the hormonal contraceptive package leaflet. If the patient is using other hormonal contraceptives (such as a vaginal ring, implant, or intrauterine system), use an additional non-hormonal contraceptive method (e.g., condoms) for the next 7 days and follow the recommendations in the package leaflet for that product.

Effect on laboratory test results

Usually, Sugammadex AptaPharma does not affect laboratory test results. However, it may affect the results of blood tests for a hormone called progesterone. If the patient's progesterone level in the blood needs to be tested on the same day that Sugammadex AptaPharma is administered, inform the doctor.

Pregnancy and breastfeeding

Inform the anesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding. The patient can still be given Sugammadex AptaPharma, but this should be discussed with the doctor. It is not known whether sugammadex passes into breast milk. The anesthesiologist will help the patient decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefits of breastfeeding for the baby and the benefits of treatment with Sugammadex AptaPharma for the mother.

Driving and using machines

Sugammadex AptaPharma has no known effect on the ability to drive or use machines.

Sugammadex AptaPharma contains sodium

This medicine contains up to 9.3 mg of sodium (the main component of common salt) per milliliter. This corresponds to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How is the medicine administered

Sugammadex AptaPharma will be administered to the patient by an anesthesiologist, or under the supervision of an anesthesiologist.

Dose

The anesthesiologist will adjust the dose of Sugammadex AptaPharma based on:

• body weight
• dose of muscle relaxant used.

The usual dose is from 2 mg/kg body weight to 4 mg/kg body weight in adults and children and adolescents aged 2-17 years. If rapid recovery of muscle tension is necessary, a dose of 16 mg/kg body weight can be used in adults.

How is the medicine administered

Sugammadex AptaPharma is administered by an anesthesiologist. It is given as a single injection through an intravenous line.

If more Sugammadex AptaPharma is administered than recommended

Since the anesthesiologist closely monitors the patient's condition, it is unlikely that an overdose of Sugammadex AptaPharma will occur. Nevertheless, in the event of such an occurrence, no problems should arise. 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, Sugammadex AptaPharma can cause side effects, although not everybody gets them. If these side effects occur during anesthesia, they will be noticed and treated by the anesthesiologist.

Common side effects (may affect up to 1 in 10 people)

• Cough
• Difficulty breathing, including coughing or moving, such as when waking up or taking a breath
• Mild anesthesia - the patient may start to wake up from deep sleep and need more anesthetic. This can cause movement or coughing at the end of the operation
• Complications during the procedure, such as changes in heart rate, coughing, or movement

Decreased blood pressure related to the surgical procedure

Uncommon side effects (may affect up to 1 in 100 people)

• Shortness of breath due to bronchospasm in patients with a history of lung disease
• Allergic reactions (hypersensitivity to the medicine) - such as rash, skin redness, swelling of the tongue and/or throat, difficulty breathing, changes in blood pressure or heart rate, sometimes resulting in severe low blood pressure. Severe allergic reactions or reactions similar to allergic reactions can be life-threatening. Allergic reactions have been reported more frequently in healthy, conscious volunteers
• Recovery of muscle tension after surgery

Side effects of unknown frequency(frequency cannot be estimated from available data)

• After administration of Sugammadex AptaPharma, severe cases of bradycardia, including bradycardia leading to cardiac arrest, are possible

Reporting side effects

If you experience any side effects, including those not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Drug Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex AptaPharma

The medicine will be stored by medical personnel. Store the medicine out of 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. Store below 30°C. Do not freeze. Store the vial in the outer packaging to protect from light. After first opening and dilution, chemical and physical stability has been demonstrated for 48 hours at a temperature of 2°C to 25°C, in a location protected from natural light. 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 would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

6. Contents of the pack and other information

The active substance is sugammadex. 1 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 (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

What Sugammadex AptaPharma looks like and contents of the pack

Sugammadex AptaPharma is a clear solution for injection with a color from colorless to slightly yellow-brown. It is available in two different pack sizes containing 10 vials of 2 mL or 10 vials of 5 mL solution for injection. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder
Apta Medica Internacional d.o.o.
Likozarjeva ulica 6
1000 Ljubljana
Slovenia
Tel.:00386 51 615 015
e-mail: info@apta-medica.com
Manufacturer
LABORATORIOS NORMON S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos – Madrid
Spain

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

Austria
Sugammadex AptaPharma 100 mg/ml Injektionslösung
Bulgaria
Сугамадекс АптаФарма 100 mg/ ml инжекционен разтвор
Croatia
Sugammadeks AptaPharma 100 mg/ml otopina za injekciju
Czech Republic
Sugammadex AptaPharma
Poland
Sugammadex AptaPharma
Romania
Sugammadex AptaPharma 100 mg/ml soluție injectabilă
Slovakia
Sugammadex AptaPharma 100 mg/ml injekčný roztok
Slovenia
Sugamadeks AptaPharma 100 mg/ml raztopina za injiciranje
Hungary
Sugammadex AptaPharma 100 mg/ml oldatos injekció

Date of last revision of the package leaflet:

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Information intended for healthcare professionals only:

To obtain detailed information, refer to the Summary of Product Characteristics for Sugammadex AptaPharma.