Sugammadex Noridem

PATIENT INFORMATION LEAFLET

Leaflet attached to the packaging: information for the patient

Sugammadex Noridem, 100 mg/mL, solution for injection

Sugammadex

Read the leaflet carefully before taking the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult an anesthesiologist or another doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the anesthesiologist or another doctor. See section 4.

Table of contents of the leaflet

• 1. What is Sugammadex Noridem and what is it used for
• 2. Important information before taking Sugammadex Noridem
• 3. How Sugammadex Noridem is administered
• 4. Possible side effects
• 5. How to store Sugammadex Noridem
• 6. Package contents and other information

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

What is Sugammadex Noridem

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

What is Sugammadex Noridem 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 relaxants and include rocuronium bromide and vecuronium bromide. Since these drugs 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 Noridem is used to accelerate the return of muscles to their normal state after surgery, so that the patient can breathe on their own as soon as possible. Its action involves binding to rocuronium bromide or vecuronium bromide in the body. The drug can be used in adults when rocuronium bromide or vecuronium bromide has been administered, as well as in children and adolescents (aged 2 to 17) when rocuronium bromide has been administered for moderate muscle relaxation.

2. Important information before taking Sugammadex Noridem

When not to take Sugammadex Noridem

Warnings and precautions

Before taking Sugammadex Noridem, discuss it with the anesthesiologist

Children and adolescents

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

Sugammadex Noridem and other medicines

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

Some medicines reduce the effectiveness of Sugammadex Noridem

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

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

Sugammadex Noridem may affect the effectiveness of hormonal contraceptives

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

Effect on blood test results

Normally, Sugammadex Noridem does not affect laboratory test results. However, it may affect the results of blood tests for a hormone called progesterone. Consult a doctor if the progesterone level in the blood needs to be tested on the same day that Sugammadex Noridem is administered.

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 Noridem, 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 Noridem for the mother.

Driving and using machines

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

Sugammadex Noridem contains sodium

This medicine contains 9.19 mg of sodium (the main component of common salt) per milliliter. This corresponds to 0.46% of the maximum recommended daily intake of sodium in the diet for adults.

3. How Sugammadex Noridem is administered

Sugammadex Noridem 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 Noridem based on:

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

How Sugammadex Noridem is administered

Sugammadex Noridem is administered by an anesthesiologist. It is given as a single injection through an intravenous line (intravenous administration).

If more Sugammadex Noridem is administered than recommended

Since the anesthesiologist closely monitors the patient's condition, overdose of Sugammadex Noridem is unlikely. Nevertheless, in the event of such an occurrence, no problems should arise. If there are any further doubts about the use of this medicine, consult an 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 during anesthesia, they will be noticed and treated by the anesthesiologist.

Frequent side effects (may occur in 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 product. This can cause movement or coughing at the end of the operation
• Complications during the procedure, such as changes in heart rate, coughing, or moving
• Decreased blood pressure related to the surgical procedure

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

• Shortness of breath associated with 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, shortness of breath, changes in blood pressure or heart rate, sometimes resulting in severe hypotension. 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

Frequency not known (cannot be estimated from available data)

• After administration of Sugammadex Noridem, severe cases of bradycardia and bradycardia up to cardiac arrest are possible

Reporting side effects

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

5. How to store Sugammadex Noridem

The medicine will be stored by healthcare professionals. The medicine should be stored 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. There are no special storage temperature recommendations for the medicine. Store the ampoules in the outer packaging to protect from light. After first opening and dilution, chemical and physical stability has been demonstrated during use for a period of 48 hours at a temperature of 2°C to 8°C and at 25°C at a sugammadex concentration of 10 mg/mL. Considering microbiological aspects, the diluted product should be used immediately. If not used immediately, the user is responsible for the storage time and conditions during use, which should not exceed 24 hours at a temperature of 2°C to 8°C, unless the dilution was performed under controlled and validated aseptic conditions.

6. Package contents and other information

What Sugammadex Noridem contains

• The active substance is sugammadex. Each milliliter of solution for injection contains sugammadex sodium equivalent to 100 mg of sugammadex. Each 2 mL ampoule contains sugammadex sodium equivalent to 200 mg of sugammadex. Each 5 mL ampoule contains sugammadex sodium equivalent to 500 mg of sugammadex.
• The other ingredients are: water for injections, hydrochloric acid 1N (for pH adjustment), and sodium hydroxide 1N (for pH adjustment).

What Sugammadex Noridem looks like and contents of the pack

Sugammadex Noridem is a clear solution for injection, colorless to slightly yellowish. Ampoules made of colorless glass type I containing 2 mL or 5 mL of solution for injection, packaged in cardboard boxes. Pack sizes: 10 ampoules of 2 mL or 10 ampoules of 5 mL. Not all pack sizes may be marketed.

Responsible entity:

Noridem Enterprises Limited, Evagorou & Makariou, Mitsi Building 3, Office 115, Nikosia, 1065, Cyprus

Manufacturer:

Demo S.A. PHARMACEUTICAL INDUSTRY, 21st km National Road Athens-Lamia, 14568 Krioneri, Attiki, Greece, T: +30 210 8161802, F: +30 2108161587.

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

Finland, Sugammadex Noridem 100 mg/ml Injektioneste, liuos, Greece, Sugammadex/ DEMO 100 mg/ml Ενέσιμο διάλυμα, Germany, Sugammadex Noridem 100 mg/ml Injektionslösung, Denmark, Sugammadex Noridem, France, SUGAMMADEX NORIDEM 100 mg/mL, solution injectable, Ireland, Sugammadex 100 mg/ml Solution for injection, Poland, Sugammadex Noridem, Sweden, Sugammadex Noridem, Netherlands, Sugammadex Noridem 100 mg/ml Oplossing voor injectie, Portugal, Sugamadex Noridem, Norway, Sugammadex Noridem, Italy, Sugammadex Noridem

Date of last revision of the leaflet:

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Information intended for healthcare professionals only:
To obtain detailed information, refer to the Summary of Product Characteristics of Sugammadex Noridem.