Package leaflet: Information for the user

Sugammadex Juta, 100 mg/mL, solution for injection
Sugammadexum
Please read all of 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 anaesthetist or another doctor.
If you experience any adverse reactions, including any not listed in this leaflet, tell your anaesthetist or another doctor immediately. See section 4.

Leaflet contents

What Sugammadex Juta is and what it is used for
What you need to know before receiving Sugammadex Juta
How Sugammadex Juta is administered
Possible side effects
How to store Sugammadex Juta
Contents of the pack and other information

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

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

Why Sugammadex Juta is used
During certain types of surgery, the patient's muscles must be completely relaxed. This enables the surgeon to perform the procedure more easily. For this reason, muscle relaxants are administered during general anaesthesia. These are known as neuromuscular blocking agents, and include rocuronium bromide and vecuronium bromide.
Because these medicines also relax the respiratory muscles, assisted ventilation (mechanical ventilation) is required during and after surgery until the patient's spontaneous breathing returns.

Sugammadex Juta is used to accelerate the recovery of normal muscle function after surgery, enabling the patient to breathe independently sooner.
It works by binding to rocuronium bromide or vecuronium bromide in the body.

Sugammadex Juta may 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 Juta

When not to administer Sugammadex Juta

if the patient has a hypersensitivity 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 Juta, discuss the following with the anaesthesiologist:

if the patient currently has or has previously had kidney disease. This is important because Sugammadex Juta 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 is taking anticoagulant medicines.

Sugammadex Juta 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 Juta may affect the action of other medicines, or other medicines may affect the action of Sugammadex Juta.
Some medicines reduce the effectiveness of Sugammadex Juta
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 Juta may affect the efficacy of hormonal contraceptives
Sugammadex Juta may reduce the effectiveness of hormonal contraceptives, including oral contraceptive pills, vaginal contraceptive systems, implants, or intrauterine delivery systems releasing progestogen (hormonal intrauterine device), because it reduces the amount of hormone delivered. The amount of progestogen lost due to administration of Sugammadex Juta is approximately equivalent to missing one oral contraceptive pill.

If taking an oral contraceptive pill on the same day that Sugammadex Juta is administered, follow the instructions for missed pill as described in the patient leaflet of the hormonal contraceptive.
If using other hormonal contraceptives (such as a vaginal contraceptive system, implant, or hormonal intrauterine device), use an additional non-hormonal contraceptive method (e.g. condoms) for the next 7 days and follow the recommendations provided in the leaflet of the specific contraceptive product.

Effect on blood test results
Generally, Sugammadex Juta does not affect laboratory test results. However, it may affect blood tests measuring levels of a hormone called progesterone. Please consult your doctor if progesterone levels need to be tested on the same day that Sugammadex Juta is administered.

Pregnancy and breastfeeding
Inform the anaesthesiologist if the patient is pregnant, may be pregnant, or is breastfeeding.
Sugammadex Juta 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 sugammadex treatment, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Sugammadex Juta for the mother.

Driving and operating machinery
Sugammadex Juta has no known effect on the ability to drive or operate machinery.

Sugammadex Juta 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 Sugammadex Juta is administered

Sugammadex Juta 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 Juta based on:

body weight
the dose of neuromuscular blocking agent used.

The usual dose ranges from 2 mg/kg to 4 mg/kg body weight in patients of all ages. If rapid reversal of neuromuscular blockade is urgently required, a dose of 16 mg/kg body weight may be used in adults.
How Sugammadex Juta is administered
Sugammadex Juta is administered by the anaesthesiologist as a single intravenous injection through an intravenous line.
If more Sugammadex Juta has been administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex Juta is unlikely. However, even if this occurs, no significant problems are expected.
If you have any further questions regarding the use of this medicine, please consult your anaesthesiologist or another doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody will experience them.
If these side effects occur during anaesthesia, they will be noticed and treated
by the anaesthetist.
Common side effects (may affect up to 1 in 10 people)

Coughing
Breathing difficulties, including coughing or movement, such as during awakening or when taking a breath
Light anaesthesia – the patient may start to wake up from deep sleep and 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
Reduced blood pressure related to the surgical procedure

Uncommon side effects (may affect up to 1 in 100 people)

Shortness of breath due to bronchial muscle spasms (bronchospasm) 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, difficulty breathing, 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 tension to normal after surgery

Frequency not known

After administration of Sugammadex Juta, severe cases of slowed heart rate, including slowing of the heart rate up to and including cardiac arrest, are possible

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

5. How to store Sugammadex Juta

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the outer carton and label after "EXP". The expiry date refers to the last day of the specified month.
This medicine will be stored by healthcare professionals.
There are no special temperature storage requirements. Store the vials in the outer packaging to protect from light. Do not freeze.
After first opening and dilution, store at a temperature of 2°C to 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. Such measures help protect the environment.

6. Contents of the pack and other information

What Sugammadex Juta contains

The active substance is sugammadex. 1 mL of the 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 components are: water for injections, hydrochloric acid and (or) sodium hydroxide.

What Sugammadex Juta looks like and contents of the pack
Sugammadex Juta is a clear, colourless to slightly yellow injection solution.
It is available in two different pack sizes containing 1 vial, 5 vials or 10 vials of 2 mL or 1 vial, 5 vials or 10 vials of 5 mL of injection solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Juta Pharma GmbH
Gutenbergstraße 13
24941 Flensburg
Germany
[email protected]

This medicinal product is authorised in the European Economic Area member states under the following names:
Germany Sugammadex Juta 100 mg/ml Injektionslösung
Austria Sugammadex Juta 100 mg/ml Injektionslösung
France Sugammadex Juta Pharma 100 mg/ml, solution injectable
Ireland Sugammadex Juta 100mg/ml solution for injection
Italy Sugammadex Juta 100 mg/mL soluzione iniettabile
Poland Sugammadex Juta, 100 mg/mL, roztwór do wstrzykiwań
Portugal Sugamadex Juta 100 mg/ml solução injetável
Spain Sugammadex Juta 100mg/mL solución Inyectable EFG

Information intended exclusively for healthcare professionals:

For detailed information, please refer to the Summary of Product Characteristics for
Sugammadex Juta.