Sugammadex noridem

Package leaflet: Information for the patient

Sugammadex Noridem, 100 mg/mL, solution for injection
Sugammadexum
Please read this leaflet carefully before the medicine is administered, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, please ask your anaesthesiologist or another doctor.
• If you experience any adverse reactions, including any not listed in this leaflet, inform your anaesthesiologist or another doctor immediately. See section 4.

Leaflet contents

1. What is Sugammadex Noridem and what is it used for
2. Important information before receiving Sugammadex Noridem
3. How Sugammadex Noridem is administered
4. Possible side effects
5. How to store Sugammadex Noridem
6. Contents of the pack 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 muscle relaxant binding agent, because it acts only on specific muscle relaxants – rocuronium bromide or vecuronium bromide.
Why is Sugammadex Noridem used
During certain types of surgery, the patient's muscles must be completely relaxed. This allows the surgeon to perform the procedure more easily. For this purpose, muscle relaxants are administered during general anaesthesia. These are known as neuromuscular blocking agents and include rocuronium bromide and vecuronium bromide.
Since these drugs also relax the respiratory muscles, assisted ventilation (mechanical ventilation) is required during and after surgery until the patient's spontaneous breathing returns.
Sugammadex Noridem is used to accelerate the recovery of normal muscle function after surgery, enabling earlier restoration of spontaneous breathing. It works by 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, and also in children and adolescents (aged 2 to 17 years) when rocuronium bromide has been used to achieve moderate to profound muscle relaxation.

2. Important information before administration of Sugammadex Noridem

When not to administer Sugammadex Noridem

• if the patient is allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6). → In such case, the anaesthesiologist must be informed.

Warnings and precautions
Before administration of Sugammadex Noridem, discuss with the anaesthesiologist:

• if the patient currently suffers or has previously suffered from kidney disease. This is important because Sugammadex Noridem is eliminated from the body via the kidneys.
• if the patient currently has or has previously had liver diseases.
• if the patient has fluid retention in the body (edema).
• if the patient has diseases known to increase the risk of bleeding (blood coagulation disorders) or is taking anticoagulant medicines.

Children and adolescents
Use of this medicine is not recommended in infants under 2 years of age.
Sugammadex Noridem and other medicines
→ Inform the anaesthesiologist about all medicines currently taken or 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 particularly important to inform the anaesthesiologist if the patient has recently taken any of the following medicines:

• toremifene (used in the treatment of breast cancer).
• fusidic acid (an antibiotic).

Sugammadex Noridem may affect the effectiveness of hormonal
contraceptive products

• This product may reduce the effectiveness of hormonal contraceptive products, including oral contraceptives ("the pill"), vaginal contraceptive systems, implants, or intrauterine systems releasing progestogen (hormonal intrauterine device), because it reduces the amount of hormone delivered. The amount of progestogen lost due to administration of Sugammadex Noridem is approximately equivalent to missing one dose of a hormonal contraceptive. → If taking an oral contraceptive ("the pill") on the same day that Sugammadex Noridem is administered, follow the instructions for missed dose provided in the package leaflet of the hormonal contraceptive product. → For use of other hormonal contraceptives (such as vaginal contraceptive systems, implants, or hormonal intrauterine devices), an additional non-hormonal method of contraception (e.g., condoms) should be used for the next 7 days, and follow the recommendations provided in the product leaflet.

Effect on blood test results
Generally, Sugammadex Noridem does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Please consult your doctor if measurement of blood progesterone levels is required on the same day that Sugammadex Noridem is administered.
Pregnancy and breastfeeding
→ Inform the anaesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding.
Sugammadex Noridem may still be used in pregnant patients, but this should be discussed with the doctor.
It is not known whether sugammadex passes into human milk. The anaesthesiologist will help the patient decide whether to discontinue breastfeeding or to refrain from treatment with sugammadex, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Sugammadex Noridem for the mother.
Driving and operating machinery
Sugammadex Noridem has no known effect on the ability to drive or operate machinery.
Sugammadex Noridem contains sodium
This medicine contains 9.19 mg of sodium (the main component of table salt) per millilitre.
This corresponds to 0.46% of the maximum recommended daily dietary sodium intake for adults.

3. How is Sugammadex Noridem administered

Sugammadex Noridem will be administered to the patient by an anaesthesiologist, or under the supervision of an anaesthesiologist.
Dosage
The anaesthesiologist will adjust the dose of Sugammadex Noridem based on:

• body weight
• the dose of the muscle relaxant used. The usual dose ranges from 2 mg/kg to 4 mg/kg body weight in adults and children and adolescents aged 2–17 years. If rapid reversal of neuromuscular blockade is required, a dose of 16 mg/kg body weight may be used in adults.

How Sugammadex Noridem is administered
Sugammadex Noridem is administered by an anaesthesiologist as a single intravenous injection through an intravenous line (intravenous administration).
If more Sugammadex Noridem has been administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose is unlikely. Nevertheless, if such an event occurs, no problems are expected to arise.
If you have any further doubts regarding the use of this medicine, please consult the anaesthesiologist or another physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If these adverse reactions occur during anaesthesia, they will be noticed and treated by the anaesthesiologist.
Common adverse reactions (may occur in up to 1 in 10 people)

• Coughing
• Breathing difficulties, including coughing or movement, such as during emergence or taking a breath
• Light anaesthesia – the patient may begin to wake up from deep sleep and require additional anaesthetic agent. This may result in movement or coughing towards the end of surgery
• Complications during the procedure, such as changes in heart rate, coughing or movement
• Reduced blood pressure related to the surgical procedure

Uncommon adverse reactions (may occur in up to 1 in 100 people)

• Shortness of breath due to bronchial muscle spasm (bronchospasm) occurring in patients with a history of lung disease
• Allergic reactions (hypersensitivity to the medicine) – such as rash, redness of the skin, swelling of the tongue and (or) throat, shortness of breath, changes in blood pressure or heart rhythm, sometimes leading to severe drop in blood pressure. Severe allergic or allergic-like reactions may be life-threatening. Allergic reactions have been reported more frequently in healthy, awake volunteers
• Return of muscle tone to normal state after surgery

Frequency not known (cannot be estimated from available data)

• After administration of Sugammadex Noridem, severe cases of bradycardia (slow heart rate), including slowing of the heart rate up to cardiac arrest, are possible

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the anaesthesiologist or another doctor. Adverse reactions can also be reported directly to the Department of Monitoring of Adverse Reactions of Medicinal Products, Office for Registration of 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 adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Sugammadex Noridem

Sugammadex Noridem will be stored by healthcare professionals.
Keep 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 stated month.
There are no special storage temperature requirements for this medicine.
Store the vials 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 temperatures from 2°C to 8°C and at 25°C with a sugammadex concentration of 10 mg/mL. However, from a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the responsibility for storage conditions and duration during use lies with the user, and the storage time should not exceed 24 hours at a temperature of 2°C to 8°C, unless the dilution was carried out under controlled and validated aseptic conditions.

6. Package contents and other information

What Sugammadex Noridem contains

• The active substance is sugammadex. Each mL of concentrate for solution for injection 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 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, colourless to slightly yellow solution for injection.
Vials made of colourless type I glass containing 2 mL or 5 mL of solution for injection, packed in cardboard boxes.
Pack sizes: 10 vials of 2 mL or 10 vials of 5 mL.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
Noridem Enterprises Limited
Evagorou & Makariou
Mitsi Building 3
Office 115, Nicosia
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 medicinal product is authorised in 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

Information intended exclusively for healthcare professionals:

For detailed information, please refer to the Product Characteristics
of the medicinal product Sugammadex Noridem.