Package leaflet: Information for the user

Sugammadex Reddy, 100 mg/ml, solution for injection
Sugammadexum
Please read all of this leaflet carefully before this medicine is administered, because it contains
important information for you.

Keep this leaflet, as you may need to read it again.
If you have any further questions, ask 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.

Contents of the leaflet

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

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

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

Why Sugammadex Reddy is used
During certain types of surgery, a patient's muscles must be completely relaxed. This allows the surgeon to perform the procedure more easily. For this purpose, muscle-relaxing medicines 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 Reddy is used to accelerate the 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. The medicine may be used in adults when 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 muscle relaxation.

2. Important information before administration of Sugammadex Reddy

When not to administer Sugammadex Reddy

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

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

if the patient has or has previously had kidney diseases. This is important because Sugammadex Reddy is eliminated from the body via the kidneys.
if the patient currently has or has previously had liver diseases.
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.

Children and adolescents
Use of this medicine is not recommended in children under 2 years of age.
Sugammadex Reddy 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 Reddy may affect the action of other medicines, or other medicines may affect the action of Sugammadex Reddy.
Some medicines reduce the effectiveness of Sugammadex Reddy
→ 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 Reddy may affect the effectiveness of hormonal contraceptives

Sugammadex Reddy may reduce the effectiveness of hormonal contraceptives, including oral contraceptives ("the pill"), vaginal contraceptive systems, implants, or transdermal contraceptive systems releasing progestogen (hormonal intrauterine devices), because it reduces the amount of hormone delivered. The amount of progestogen lost due to administration of Sugammadex Reddy is approximately equivalent to missing one oral contraceptive tablet. → If taking "the pill" on the same day that Sugammadex Reddy is administered, follow the instructions for missed oral contraceptive dose provided in the package 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 in the product leaflet of the specific contraceptive.

Effect on blood test results
Generally, Sugammadex Reddy does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Consult the doctor if measurement of blood progesterone levels is required on the same day that Sugammadex Reddy is administered.
Pregnancy and breastfeeding
→ Inform the anaesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding.
Sugammadex Reddy may still be used in pregnant patients, but this should be discussed with the doctor.
It is unknown whether sugammadex passes into breast 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 Reddy for the mother.
Driving and operating machinery
Sugammadex Reddy has no known effect on the ability to drive or operate machinery.
Sugammadex Reddy 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 Reddy administered

Sugammadex Reddy 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 Reddy based on:

the patient's body weight
the dose of neuromuscular blocking agent used. The usual dose ranges from 2 mg/kg 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 Reddy is administered
Sugammadex Reddy is administered by an anaesthesiologist as a single intravenous injection through an intravenous line.
Administration of a higher than recommended dose of Sugammadex Reddy
The anaesthesiologist will closely monitor the patient's condition, making overdose of Sugammadex Reddy unlikely. Nevertheless, even if such an event occurs, no problems are expected.
If you have any further questions regarding the use of this medicine, please consult your 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 anaesthetist.

Common adverse reactions (may occur in up to 1 in 10 people)

Cough
Breathing difficulties, including cough or movement, such as during emergence or during inspiration
Light anaesthesia – the patient may begin to wake up from deep sleep and may require additional anaesthetic agent. This may result in movement or coughing towards the end of surgery
Intraoperative complications such as changes in heart rate, cough, or movement
Decreased arterial blood pressure related to 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, redness of the skin, swelling of the tongue and (or) throat, shortness of breath, changes in blood pressure or heart rhythm, sometimes leading to severe hypotension. Severe allergic reactions or reactions resembling allergic reactions may be life-threatening. Allergic reactions have been reported more frequently in healthy, awake volunteers
Return of muscle tension to normal state after surgery

Frequency not known

Following administration of Sugammadex Reddy, severe cases of bradycardia are possible, including slowing of the heart rate up to and including cardiac arrest

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform your anaesthetist 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 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. By reporting adverse reactions, additional information on the safety of the medicine can be collected.

5. How to store Sugammadex Reddy

The medicine will be stored by healthcare personnel.
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 following “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 2°C to 8°C and use within 24 hours.

6. Contents of the pack and other information

What Sugammadex Reddy contains

The active substance is sugammadex. 1 ml 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 and, for pH adjustment: sodium hydroxide 0.04% and hydrochloric acid 0.3%.
What Sugammadex Reddy looks like and contents of the pack
Sugammadex Reddy is a clear, colourless to slightly yellow solution for injection in a transparent glass vial.
Pack sizes:
10 vials of 2 ml
10 vials of 5 ml
Not all pack sizes may be marketed.
Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Reddy Holding GmbH
Kobelweg 95
86156 Augsburg
Germany
Tel.: +49 821 74881 0
Manufacturer/Importer
betapharm Arzneimittel GmbH
Kobelweg 95
86156 Augsburg
Germany
DR. REDDY’S LABORATORIES ROMÂNIA S.R.L.
Str.Daniel Danielopolu, nr. 30-32, Spatiul2, Etaj 5, Sectorul 1
014134 Bucharest 1
Romania
Rual Laboratories S.R.L.
Splaiul Unirii 313, Building H, 1st Floor, Sector 3
030138 Bucharest
Romania
This medicinal product is authorised in the European Economic Area countries under the following names:
Germany Sugammadex beta 100 mg/ml Injektionslösung
Spain Sugammadex Dr. Reddys 100 mg/ml solución inyectable EFG
France SUGAMMADEX REDDY PHARMA 100 mg/ml, solution injectable
Italy Sugammadex Dr. Reddy’s
Romania Sugammadex Dr. Reddy’s 100 mg/ml soluție injectabilă
Austria Sugammadex Reddy 100 mg/ml Injektionslösung
Belgium Sugammadex Reddy 100 mg/ml oplossing voor injectie
Czech Republic Sugammadex Reddy
Denmark Sugammadex Reddy
Finland Sugammadex Reddy 100 mg/ml injektioneste,liuos
Hungary Sugammadex Reddy 100 mg/ml oldatos injekció
Ireland Sugammadex 100 mg/ml solution for injection
Netherlands Sugammadex Reddy 100 mg/ml oplossing voor injectie
Norway Sugammadex Reddy
Poland Sugammadex Reddy
Portugal Sugammadex Reddy 100 mg/ml solução injetável
Sweden Sugammadex Reddy 100 mg/ml injektionsvätska, lösning
Slovakia Sugammadex Reddy 100 mg/ml injekčný roztok