Sugammadex Sandoz

Package Leaflet: Information for the User

Sugammadex Sandoz, 100 mg/ml, Solution for Injection

Sugammadex

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

• Keep this package leaflet, you may need to read it again.
• If you have any further questions, ask your anaesthesiologist or another doctor.
• If you experience any side effects, including any not listed in this package leaflet, tell your anaesthesiologist or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

What is Sugammadex Sandoz

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

What is Sugammadex Sandoz 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 anaesthesia. 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 Sandoz 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 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 years) when rocuronium bromide has been administered for moderate muscle relaxation.

2. Important information before using Sugammadex Sandoz

When not to use Sugammadex Sandoz

Warnings and precautions

Before using Sugammadex Sandoz, discuss with the anaesthesiologist if:

• the patient currently has or has had kidney disease. This is important because Sugammadex Sandoz is eliminated from the body by the kidneys.
• the patient currently has or has had liver disease.
• the patient has fluid retention in the body (oedema).
• the patient has diseases that are known to increase the risk of bleeding (blood coagulation disorders) or is taking anticoagulant medications.

Children and adolescents

The use of this medicine is not recommended in children under 2 years of age.

Sugammadex Sandoz and other medicines

Tell the anaesthesiologist about all medicines the patient is taking or has recently taken, as well as any medicines the patient plans to take. Sugammadex Sandoz may affect the action of other medicines or other medicines may affect the action of Sugammadex Sandoz. Some medicines reduce the effectiveness of Sugammadex Sandoz. It is especially important to inform the anaesthesiologist if the patient has recently taken:

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

Sugammadex Sandoz may affect the effectiveness of hormonal contraceptives

Sugammadex Sandoz 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 Sandoz is roughly equivalent to missing one contraceptive pill. → If the "pill" is taken on the same day that Sugammadex Sandoz is administered, follow the instructions for missing a "pill" contained in the hormonal contraceptive package leaflet. → If other hormonal contraceptives are used (such as a vaginal ring, implant, or hormonal intrauterine device), use an additional non-hormonal contraceptive method (e.g. condoms) for the next 7 days and follow the recommendations contained in the package leaflet for the specific product.

Effect on laboratory test results

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

Pregnancy and breastfeeding

If the patient is pregnant, thinks she may be pregnant, or is breastfeeding, she should consult her anaesthesiologist. The patient can still be given Sugammadex Sandoz, but this should be discussed with the doctor beforehand. It is not known whether sugammadex passes into breast milk. The anaesthesiologist 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 Sandoz for the mother.

Driving and using machines

The effect of Sugammadex Sandoz on the ability to drive and use machines is not known.

Sugammadex Sandoz contains sodium

The medicine contains 9.7 mg of sodium (the main component of common salt) per millilitre. A 2 ml vial of the medicine contains less than 23 mg of sodium, which means it is essentially "sodium-free". A 5 ml vial of the medicine contains 48.5 mg of sodium (the main component of common salt), which corresponds to 2.5% of the maximum daily intake of 2 g of sodium recommended by the World Health Organization for an adult.

3. How is Sugammadex Sandoz administered

Sugammadex Sandoz is administered by an anaesthesiologist or under their supervision.

Dose

The anaesthesiologist will adjust the dose of Sugammadex Sandoz based on:

• the patient's body weight
• the intensity of the muscle relaxant effect in the patient. The usual dose is from 2 mg/kg body weight (bw) to 4 mg/kg body weight for adults and for children and adolescents aged 2 to 17 years. If rapid recovery of muscle tension is necessary, a dose of 16 mg/kg bw can be used in adults.

How is Sugammadex Sandoz administered

Sugammadex Sandoz is administered by an anaesthesiologist. It is given as a single injection through an intravenous line.

Overdose of Sugammadex Sandoz

Since the anaesthesiologist closely monitors the patient's condition, it is unlikely that Sugammadex Sandoz will be overdosed. 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 anaesthesiologist or another doctor.

4. Possible side effects

Like all medicines, Sugammadex Sandoz can cause side effects, although not everybody gets them. If any of the following side effects occur during anaesthesia, they will be noticed and treated by the anaesthesiologist.

Frequent side effects (may occur in less than 1 in 10 people)

• Cough
• Difficulty breathing, including coughing or moving, such as when waking up or taking a breath
• Mild sedation - the patient may start to wake up from deep sleep and need more anaesthetic. This may 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 less than 1 in 100 people)

• Shortness of breath due to bronchospasm (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.

Unknown frequency

• After administration of Sugammadex Sandoz, severe cases of bradycardia, as well as bradycardia, up to cardiac arrest, are possible

Reporting side effects

If you experience any side effects, including any not listed in this package leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of Medicinal Products 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 authorisation holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex Sandoz

Keep the medicine out of the sight and reach of children. Do not use this medicine after the expiry date stated on the vial and carton after EXP. The expiry date refers to the last day of the month. Do not freeze. Store the vials in the original package to protect from light. After first opening

After the first opening of the vial, the chemical and physical stability of the ready-to-use solution has been demonstrated for 96 hours at a temperature of 2 °C to 8 °C without light and at a temperature of 20 °C to 25 °C with light (withdrawal of the solution using a needle or cannula). Additionally, the solution for injection, withdrawn as described above, has chemical and physical stability in polypropylene syringes for 96 hours at a temperature of 2 °C to 8 °C without light and at a temperature of 20 °C to 25 °C with light. From a microbiological point of view, the product should be used immediately. If the solution is not used immediately, the user is responsible for the storage conditions and duration, 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. After dilution

After dilution, the physico-chemical stability of the ready-to-use solution has been demonstrated for 48 hours at a temperature of 2 °C to 25 °C. From a microbiological point of view, the medicine should be used immediately. If the medicine is not used immediately, the user is responsible for the storage conditions and duration before use. The solution should not be stored for more than 24 hours at a temperature of 2 °C to 8 °C, unless it was diluted under controlled and validated aseptic conditions. Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Sugammadex Sandoz contains

• The active substance is sugammadex. Each millilitre of the 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 Sandoz looks like and contents of the pack

Sugammadex Sandoz is a solution for injection. It is a clear, colourless to slightly yellowish-brown solution, practically free from particulate matter, in clear glass vials of type I with a grey rubber stopper. Two pack sizes are available, containing 10 vials of 2 ml or 10 vials of 5 ml of the solution for injection.

Marketing authorisation holder

Sandoz GmbH, Biochemiestrasse 10, 6250 Kundl, Austria

Manufacturer

Lek Pharmaceuticals d.d., Verovškova 57, 1526 Ljubljana, Slovenia

This medicine is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:

Netherlands: Sugammadex Sandoz 100 mg/ml, oplossing voor injectie

Austria: Sugammadex Sandoz 100 mg/ml - Injektionslösung

Belgium: Sugammadex Sandoz 100 mg/ml oplossing voor injectie

Czech Republic: Sugammadex Sandoz

Denmark: Sugammadex HEXAL 100 mg/ml Injektionslösung

Greece: Sugammadex/Sandoz 100 mg/mL ενέσιμο διάλυμα

Spain: Sugammadex Sandoz 100 mg/ml solución inyectable EFG

Finland: Sugammadex Sandoz 100 mg/ml injektioneste, liuos

Croatia: Sugamadeks Sandoz 100 mg/ml otopina za injekciju

Ireland: Sugammadex Rowex 100 mg/ml solution for injection

France: Sugammadex GNR 25 mg/ml, solution à diluer pour perfusion

Ireland: Sugammadex Rowex 25 mg/ml concentrate for solution for infusion

Italy: Sugammadex Sandoz

Poland: Sugammadex Sandoz

Portugal: Sugamadex Sandoz

Romania: Sugammadex Sandoz 100 mg/ml soluție injectabilă

Slovenia: Sugamadeks Sandoz 100 mg/ml raztopina za injiciranje

Northern Ireland: Sugammadex Sandoz 100 mg/ml solution for injection

For further information about this medicine, please contact:

Sandoz Polska Sp. z o.o., ul. Domaniewska 50 C, 02-672 Warsaw, tel. 22 209 70 00

Date of last revision of the package leaflet:11/2022

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The following information is intended for healthcare professionals only:

Detailed information can be found in the Summary of Product Characteristics for Sugammadex Sandoz.