Sugammadex Teva

Leaflet attached to the packaging: information for the user

Sugammadex Teva, 100 mg/ml, solution for injection

sugammadex

Read the leaflet carefully before administering 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 Teva and what is it used for
• 2. Important information before administering Sugammadex Teva
• 3. How Sugammadex Teva is administered
• 4. Possible side effects
• 5. How to store Sugammadex Teva
• 6. Contents of the packaging and other information

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

What is Sugammadex Teva

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

What is Sugammadex Teva used for

In case of certain 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 drugs also cause relaxation of the respiratory muscles, assisted breathing (mechanical ventilation) is necessary during and after the operation until the patient's own breathing returns.
Sugammadex Teva 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 administering Sugammadex Teva

When not to administer Sugammadex Teva

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

Warnings and precautions

Before administering Sugammadex Teva, discuss it with the anesthesiologist

• if the patient has or has had kidney disease in the past. This is important because Sugammadex Teva is eliminated from the body through the kidneys.
• if the patient currently has or has had liver disease in the past.
• if the patient has fluid retention in the body (edema).
• if the patient has diseases that are known to increase the risk of bleeding (blood coagulation disorders) or is taking anticoagulant drugs.

Children and adolescents

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

Sugammadex Teva and other drugs

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

Some drugs reduce the effectiveness of Sugammadex Teva

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

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

Sugammadex Teva may affect the effectiveness of hormonal contraceptives

• Sugammadex Teva 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 Teva is roughly equivalent to missing one contraceptive pill. → If taking "the pill" on the same day Sugammadex Teva is administered, follow the instructions for missing a pill in the hormonal contraceptive leaflet, → If using otherhormonal contraceptives (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 instructions in the leaflet for the specific contraceptive.

Effect on blood test results

Usually, Sugammadex Teva 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 should be tested on the same day Sugammadex Teva 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 Teva, 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 Teva for the mother.

Driving and operating machinery

Sugammadex Teva has no known effect on the ability to drive or operate machinery.

Sugammadex Teva contains sodium

This drug contains up to 9.7 mg of sodium (the main component of common salt) per milliliter. This is equivalent to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How Sugammadex Teva is administered

Sugammadex Teva 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 Teva based on:

• body weight
• the 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 Teva is administered

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

If more Sugammadex Teva is administered than recommended

Since the anesthesiologist closely monitors the patient's condition, it is unlikely that an overdose of Sugammadex Teva will occur. Nevertheless, in the event of such an occurrence, no problems should arise.
In case of any further doubts about the use of this drug, consult an anesthesiologist or another doctor.

4. Possible side effects

Like all drugs, Sugammadex Teva 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 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. 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 due to muscle spasm of the airways (bronchospasm), occurring in patients with a history of lung disease
• Allergic reactions (hypersensitivity to the drug) - such as rash, skin redness, tongue and/or throat swelling, shortness of breath, 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. The occurrence of allergic reactions has been reported more frequently in healthy, conscious volunteers
• Return of muscle relaxation after surgery

Frequency not known

• After administration of Sugammadex Teva, severe cases of slow heart rate, as well as slow heart rate, up to cardiac arrest, are possible

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor or pharmacist. Side effects can be reported directly to the Department of Monitoring of Adverse Reactions to Medicinal Products of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +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 drug.

5. How to store Sugammadex Teva

The drug will be stored by healthcare professionals.
Store the drug out of sight and reach of children. Do not use this drug after the expiry date stated on the carton and label after "EXP". The expiry date refers to the last day of the stated month.
Do not freeze. Store the vials in the outer packaging to protect from light.
After first opening and dilution, store in a refrigerator (2°C - 8°C) and use within 24 hours.

6. Contents of the packaging and other information

What Sugammadex Teva contains

• The active substance is sugammadex. 1 ml 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, and/or sodium hydroxide.

What Sugammadex Teva looks like and what the packaging contains

Sugammadex Teva is a clear solution for injection, colorless to slightly yellow-brown.
It is available in two different packaging sizes, each containing 10 vials of 2 ml or 10 vials of 5 ml of the solution for injection.
Not all packaging sizes may be marketed.

Marketing authorization holder and manufacturer

Marketing authorization holder

Teva B.V.
Swensweg 5
2031 GA Haarlem
Netherlands

Manufacturer

PLIVA Hrvatska d.o.o.
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia
To obtain more detailed information about the drug, contact the representative of the marketing authorization holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53,
00-113 Warsaw
Phone: (22) 345 93 00

Date of last update 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 Teva.