Sugammadex Reddi

Package Leaflet: Information for the User

Sugammadex Reddy, 100 mg/ml, Solution for Injection

Sugammadex

Read the package leaflet carefully before the medicine is given, 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 another doctor. See section 4.

Contents of the Package Leaflet

• 1. What Sugammadex Reddy is and what it is used for
• 2. Important information before Sugammadex Reddy is given
• 3. How Sugammadex Reddy is given
• 4. Possible side effects
• 5. How to store Sugammadex Reddy
• 6. 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 agentbecause it only works with certain muscle relaxants – rocuronium bromide or vecuronium bromide.

What Sugammadex Reddy is 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 given during general anaesthesia. These are known as muscle relaxantsand include rocuronium bromide and vecuronium bromide. Because these medicines also cause relaxation of the respiratory muscles, assisted breathing (artificial ventilation) is necessary during and after surgery until the patient regains their own breathing. Sugammadex Reddy is used to reverse the effect of these muscle relaxants after surgery, so that the patient can breathe on their own again sooner. It works by binding to rocuronium bromide or vecuronium bromide in the body. The medicine can be given to adults when rocuronium bromide or vecuronium bromide has been used, and to children and adolescents (from 2 to 17 years old) when rocuronium bromide has been used for moderate muscle relaxation.

2. Important information before Sugammadex Reddy is given

When not to give Sugammadex Reddy

Warnings and precautions

Before Sugammadex Reddy is given, discuss with the anaesthesiologist

Children and adolescents

Sugammadex Reddy should not be given to children under 2 years of age.

Sugammadex Reddy 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 Reddy may affect the action of other medicines, or other medicines may affect the action of Sugammadex Reddy.

Some medicines reduce the effect of Sugammadex Reddy

It is especially important to tell the anaesthesiologist if the patient has taken the following medicines recently:

• Toremifene (used to treat 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 the "pill", vaginal ring, implant, or intrauterine system (IUS) releasing progestogen, because it reduces the amount of hormone delivered. The amount of progestogen lost due to Sugammadex Reddy is roughly equivalent to missing one contraceptive pill. If the "pill" is taken on the same day that Sugammadex Reddy is given, follow the instructions for missing a pill in the package leaflet for the hormonal contraceptive. If other hormonal contraceptives (such as a vaginal ring, implant, or IUS) are used, an additional non-hormonal contraceptive method (such as condoms) should be used for the next 7 days, and the instructions in the package leaflet for the product should be followed.

Effect on laboratory tests

Sugammadex Reddy usually does not affect laboratory test results. However, it may affect the results of tests for the hormone progesterone in the blood. Tell the doctor if the progesterone level in the blood needs to be checked on the same day that Sugammadex Reddy is given.

Pregnancy and breastfeeding

Tell the anaesthesiologist if the patient is pregnant or thinks she may be pregnant, or if she is breastfeeding. Sugammadex Reddy can still be given to the patient, but this should be discussed with the doctor. 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 Reddy, considering the benefits of breastfeeding for the baby and the benefits of treatment with Sugammadex Reddy for the mother.

Driving and using machines

Sugammadex Reddy has no known effect on the ability to drive or use machines.

Sugammadex Reddy contains sodium

This medicine contains up to 9.7 mg of sodium (the main component of common salt) per millilitre. This corresponds to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How Sugammadex Reddy is given

Sugammadex Reddy will be given to the patient by the anaesthesiologist or under their supervision.

Dose

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

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

How Sugammadex Reddy is given

Sugammadex Reddy is given by the anaesthesiologist as a single injection into a vein.

Overdose of Sugammadex Reddy

The anaesthesiologist will closely monitor the patient's condition, so it is unlikely that an overdose of Sugammadex Reddy will occur. However, if this happens, it is unlikely to cause any problems. 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 Reddy can cause side effects, although not everybody gets them. If these side effects occur during anaesthesia, they will be noticed and treated by the anaesthesiologist.

Common side effects (may affect up to 1 in 10 people)

• Cough
• Breathing difficulties, 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 affect up to 1 in 100 people)

• Shortness of breath due to bronchospasm (constriction of the airways) 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, difficulty breathing, 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. Allergic reactions have been reported more frequently in healthy, conscious volunteers
• Recovery of muscle function after surgery

Frequency not known

• After Sugammadex Reddy is given, severe cases of slow heart rate, including slow heart rate to the point of cardiac arrest, are possible

Reporting side effects

If side effects occur, including any not listed in this package leaflet, tell the anaesthesiologist or another doctor. Side effects can be reported directly to the Department of Drug Safety, 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 Reddy

The medicine will be stored by healthcare professionals. Store in a place 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 month. Do not freeze. Store the vials in the outer carton 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 pack and other information

What Sugammadex Reddy contains

• The active substance is sugammadex. 1 ml contains sugammadex sodium equivalent to 100 mg sugammadex. Each 2 ml vial contains sugammadex sodium equivalent to 200 mg sugammadex. Each 5 ml vial contains sugammadex sodium equivalent to 500 mg sugammadex.

The other ingredients are water for injections and to adjust the pH: sodium hydroxide 0.04% and hydrochloric acid 0.3%.

What Sugammadex Reddy looks like and contents of the pack

Sugammadex Reddy is a clear solution for injection, colourless to slightly yellowish, in a 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 Bukareszt 1, Rumunia, Rual Laboratories S.R.L., Splaiul Unirii 313, Building H, 1st Floor, Sector 3, 030138 Bucharest, Rumunia

This medicine is authorised in the Member States of the European Economic Area 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

Date of last revision of the package leaflet: April 2024