SUGAMMADEX STADA

Package leaflet: Information for the user

Sugammadex Stada, 100 mg/ml, solution for injection
sugammadex
Please read this leaflet carefully before the medicine is administered, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult 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.

Contents of the leaflet

1. What Sugammadex Stada is and what it is used for
2. What you need to know before receiving Sugammadex Stada
3. How Sugammadex Stada is administered
4. Possible side effects
5. How to store Sugammadex Stada
6. Contents of the pack and other information

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

What Sugammadex Stada is
Sugammadex Stada contains the active substance sugammadex. Sugammadex Stada is considered a selective relaxant binding agent, because it acts only on specific muscle relaxants – rocuronium bromide or vecuronium bromide.

What Sugammadex Stada is used for
During certain types of surgery, the patient's muscles must be completely relaxed to allow the surgeon easier access and better operating conditions. For this purpose, muscle-relaxing drugs are administered during general anaesthesia. These are known as muscle relaxants 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 regains spontaneous breathing.

Sugammadex Stada is used to accelerate the recovery of muscle function after surgery, enabling the patient to breathe independently again sooner. It works by binding to rocuronium bromide or vecuronium bromide in the body. The medicine can be used in adults when either rocuronium bromide or vecuronium bromide has been administered, and also in children and adolescents (aged 2 to 17 years) when rocuronium bromide has been given to achieve moderate neuromuscular blockade.

2. Important information before administration of Sugammadex Stada

When not to give Sugammadex Stada:

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

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

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

Children and adolescents
Use of this medicine is not recommended in children under 2 years of age.
Sugammadex Stada and other medicines
→ Inform the anaesthesiologist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Sugammadex Stada may affect the action of other medicines, or other medicines may affect the action of Sugammadex Stada.
Some medicines reduce the effectiveness of Sugammadex Stada
→ It is particularly important to inform the anaesthesiologist if the following medicines have been taken recently:

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

Sugammadex Stada may affect the effectiveness of hormonal contraceptives

• Sugammadex Stada may reduce the effectiveness of hormonal contraceptives, including oral contraceptives ("the pill"), vaginal contraceptive system, contraceptive implant, or transdermal contraceptive system releasing progestogen (hormonal intrauterine system), because it reduces the amount of hormone delivered. The amount of progestogen lost due to administration of Sugammadex Stada is approximately equivalent to missing one oral contraceptive tablet. → If taking "the pill" on the same day Sugammadex Stada is administered, follow the instructions for missed dose provided in the package leaflet of the hormonal contraceptive. → If using other hormonal contraceptives (such as vaginal contraceptive system, implant, or hormonal intrauterine system), use an additional non-hormonal contraceptive method (e.g. condoms) for the next 7 days and follow the recommendations provided in the package leaflet of the specific contraceptive.

Effect on blood test results
Generally, Sugammadex Stada does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Please consult a doctor if progesterone blood levels need to be measured on the same day Sugammadex Stada is administered.
Pregnancy and breastfeeding
→ Inform the anaesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding.
Sugammadex Stada may still be used in pregnant patients, but this should be discussed with the doctor.
It is unknown 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 Stada for the mother.
Driving and operating machinery
Sugammadex Stada has no known effect on the ability to drive or operate machinery.
Sugammadex Stada contains sodium
This medicine contains up to 9.7 mg of sodium (a main component of table salt) per millilitre. This corresponds to 0.5% of the maximum recommended daily dietary intake of sodium for adults.

3. How Sugammadex Stada is administered

Sugammadex Stada 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 Stada based on:

• the patient's body weight,
• the dose of the muscle relaxant used. The usual dose is 2 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 Stada is administered
Sugammadex Stada is administered by an anaesthesiologist as a single intravenous injection through an intravenous line.
If more Sugammadex Stada is administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex Stada is unlikely. Nevertheless, even if this occurs, no problems are expected to arise.
If you have any further questions about the use of this medicine, please consult the anaesthesiologist or another doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them. If
these adverse reactions occur during anaesthesia, they will be noticed and treated by the anaesthesiologist.
Common adverse reactions (may occur in no more than 1 in 10 people)

• Cough
• Breathing difficulties, including cough or movement, such as during waking up or taking a breath
• Light anaesthesia – the patient may begin to wake from deep sleep and may require additional anaesthetic. This may cause movement or coughing towards the end of surgery
• Complications during the procedure, such as changes in heart rate, coughing or movement
• Decreased blood pressure associated with the surgical procedure

Uncommon adverse reactions (may occur in no more than 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, skin redness, 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 weakness after surgery

Frequency not known (frequency cannot be estimated from available data)

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

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 be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C, 02-222 Warsaw
Tel.: +48 22 49 21 301, Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sugammadex Stada

The medicine will be stored by healthcare personnel.
Keep the 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 the stated month.
This medicine does not require special temperature storage conditions. Store the vials in the outer packaging to protect from light. If protection from light is not ensured, the vials must be used within 5 days.
After first opening and dilution, store between 5°C and 25°C and use within 48 hours.
From a microbiological point of view, the diluted product should be used immediately, unless the method of dilution excludes the risk of microbiological contamination. If not used immediately, the responsibility for storage duration and conditions lies with the user.
Do not use solutions that are not clear or contain visible particles.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What Sugammadex Stada contains

• The active substance is sugammadex. 1 ml contains 100 mg of sugammadex as sugammadex sodium. Each 2 ml vial contains 200 mg of sugammadex as sugammadex sodium. Each 5 ml vial contains 500 mg of sugammadex as sugammadex sodium.
• The other ingredients are: water for injections, hydrochloric acid and (or) sodium hydroxide.

What Sugammadex Stada looks like and contents of the pack
Sugammadex Stada is a clear, colourless to slightly yellowish solution for injection.
It is available in two different pack sizes containing 10 vials of 2 ml or 10 vials of 5 ml of solution for injection.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
STADA Arzneimittel AG
Stadastrasse 2-18
61118 Bad Vilbel
Germany

Manufacturers/Importers:
Centrafarm Services B.V.
Van De Reijtstraat 31 E
4814 NE Breda
The Netherlands
Clonmel Healthcare Ltd.
Waterford Road
E91 D768 Clonmel
Ireland
STADA Arzneimittel GmbH
Muthgasse 36/2
1190 Vienna
Austria

For further information, please contact the local representative of the Marketing Authorisation Holder:
Stada Pharm Sp. z o.o.
ul. Krakowiaków 44
02-255 Warsaw
Tel. +48 22 737 79 20

This medicinal product is authorised in the European Union Member States under the following names:
Austria   Sugammadex STADA 100 mg/ml Injektionslösung
Belgium   Sugammadex EG 100mg/ml oplossing voor injectie
Luxembourg Sugammadex EG 100mg/ml, solution injectable
Cyprus    SUGAMMADEX/STADA
Germany   Sugammadex STADA 100 mg/ml Injektionslösung
Denmark   Sugammadex STADA 100 mg/ml injektionsvæske, opløsning
Spain    Sugammadex STADA 100 mg/ml solución inyectable EFG
Greece    SUGAMMADEX/STADA
Finland   Sugammadex STADA 100 mg/ml injektioneste, liuos
France    SUGAMMADEX EG 100 mg/ml, solution injectable
Ireland   Sugammadex Clonmel 100 mg/ml solution for injection
Iceland   Sugammadex STADA 100 mg/ml stungulyf, lausn
Italy     Sugammadex EG
Netherlands Sugammadex CF 100 mg/ml, oplossing voor injectie
Poland    Sugammadex Stada
Norway   Sugammadex STADA
Portugal   Sugamadex STADA
Sweden   Sugammadex STADA 100 mg/ml injektionsvätska, lösning
Slovenia   Sugamadeks STADA 100 mg/ml raztopina za injiciranje

Information intended exclusively for healthcare professionals:

For detailed information, please refer to the Summary of Product Characteristics
of Sugammadex Stada product