Patient Information Leaflet

Sugammadex Teva, 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 for future reference.
If you have any questions, please consult your anaesthetist or another doctor.
If you experience any side effects, including any not listed in this leaflet, tell your anaesthetist or another doctor. See section 4.

Table of contents

What Sugammadex Teva is and what it is used for
Important information before receiving Sugammadex Teva
How Sugammadex Teva is given
Possible side effects
How to store Sugammadex Teva
Contents of the pack and other information

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

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

What Sugammadex Teva is used for
During certain types of surgery, a patient's muscles must be completely relaxed to allow the surgeon to operate 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 regains the ability to breathe independently.

Sugammadex Teva is used to accelerate recovery of muscle function after surgery, enabling earlier restoration of spontaneous breathing. It works by binding to rocuronium bromide or vecuronium bromide in the body. It can be used in adults when rocuronium bromide or vecuronium bromide has been administered.
It may also be used in newborns, infants, young children, children, and adolescents (from birth up to 17 years of age) when rocuronium bromide has been given.

2. Important information before administration of Sugammadex Teva

When not to administer Sugammadex Teva

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

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

if the patient currently suffers or has previously suffered from kidney disease. This is important because Sugammadex Teva 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 in the body (oedema).
if the patient has diseases known to increase the risk of bleeding (coagulation disorders) or is taking anticoagulant medicines.

Sugammadex Teva and other medicines
→ Inform the anaesthesiologist about all medicines currently or recently taken by the patient, as well as any medicines the patient plans to take.
Sugammadex Teva may affect the action of other medicines or other medicines may affect the action of Sugammadex Teva.
Some medicines reduce the effectiveness of Sugammadex Teva
→ 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 Teva may affect the efficacy of hormonal contraceptives

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

Effect on blood test results
Sugammadex Teva usually does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Please consult the doctor if progesterone blood levels need to be measured on the same day as administration of Sugammadex Teva.

Pregnancy and breastfeeding
→ Inform the anaesthesiologist if the patient is pregnant, may be pregnant, or is breastfeeding.
Sugammadex Teva 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 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 medicine contains up to 9.7 mg of sodium (the 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 is Sugammadex Teva administered

Sugammadex Teva 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 Teva based on:

body weight
the dose of the muscle relaxant used. The usual dose ranges from 2 mg/kg to 4 mg/kg of body weight in patients of all ages. If reversal of neuromuscular blockade is urgently required, a dose of 16 mg/kg may be used in adults. How is Sugammadex Teva administered
Sugammadex Teva is administered by an anaesthesiologist. It is given as a single intravenous injection through an intravenous line.

If more Sugammadex Teva is administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex Teva is unlikely. Nevertheless, if such an event occurs, no problems are expected to arise.
If you have any further questions 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 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 up to 1 in 10 people)

Cough
Breathing difficulties including cough or movement, such as during awakening or taking a breath
Light anaesthesia – the patient may start to wake up 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, cough, or movement
Decreased blood pressure associated with 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, 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

Following administration of Sugammadex Teva, severe cases of bradycardia (slow heart rate) are possible, including bradycardia progressing to cardiac arrest

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in
this leaflet, inform your doctor or pharmacist. Adverse reactions can be reported
directly to the Department of Monitoring Adverse Drug Reactions at 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
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps provide more information on the safety of the medicine.

5. How to store Sugammadex Teva

The medicine will be stored by healthcare professionals.
Keep this 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.
Do not freeze. Store the vials in the outer packaging to protect from light.
After first opening and dilution, store at a temperature between 2°C and 8°C and use within 24 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Sugammadex Teva contains

The active substance is sugammadex. 1 ml of injection solution 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, concentrated hydrochloric acid and (or) sodium hydroxide.

What Sugammadex Teva looks like and contents of the pack
Sugammadex Teva is a clear injection solution ranging in colour from colourless to slightly yellow-brown. It is available in two different pack sizes containing either 10 vials of 2 ml or 10 vials of 5 ml of injection solution.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Teva B.V.
Swensweg 5
2031 GA Haarlem
The Netherlands

Manufacturer
PLIVA Hrvatska d.o.o.
Prilaz baruna Filipovića 25
10000 Zagreb
Croatia

For further information about this medicinal product, please contact the representative of the Marketing Authorisation Holder:
Teva Pharmaceuticals Polska Sp. z o.o.
ul. Emilii Plater 53,
00-113 Warsaw
Tel.: (22) 345 93 00