Sugammadex Dr. Reddy's

Package leaflet: Information for the user

Sugammadex Dr. Reddy’s 100 mg/ml solution for injection

Equivalent medicine
Please read this leaflet carefully before this medicine is administered to you because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your anaesthetist or doctor.
• If you experience any side effects, including those not listed in this leaflet, inform your anaesthetist or doctor. See section 4.

Contents of this leaflet

1. What Sugammadex Dr. Reddy’s is and what it is used for
2. What you need to know before Sugammadex Dr. Reddy’s is administered
3. How Sugammadex Dr. Reddy’s is administered
4. Possible side effects
5. How to store Sugammadex Dr. Reddy’s
6. Contents of the pack and other information

1. What is Sugammadex Dr. Reddy’s and what is it used for

What is Sugammadex Dr. Reddy’s
Sugammadex Dr. Reddy’s contains the active substance sugammadex. Sugammadex Dr. Reddy’s is considered to be a Selective Muscle Relaxant Binding Agent because it selectively binds to other medicines, rocuronium bromide or vecuronium bromide, known as muscle relaxants, which relax the muscles.
What Sugammadex Dr. Reddy’s is used for
During certain types of surgery, the muscles need to be completely relaxed. This makes the surgeon’s task easier. For this purpose, muscle-relaxing medicines are added to the general anaesthesia being administered. These medicines are called muscle relaxants, and include rocuronium bromide and vecuronium bromide. Since these medicines also relax the muscles that control breathing, assistance with breathing (so-called artificial ventilation) is required during and after surgery, until you are able to breathe on your own again.
Sugammadex Dr. Reddy’s is used to speed up muscle recovery after surgery, enabling you to breathe on your own again as soon as possible. It works by binding to rocuronium bromide or vecuronium bromide present in the body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used, and in children and adolescents (aged between 2 and 17 years) when rocuronium bromide is used for moderate levels of muscle relaxation.

2. What you need to know before Sugammadex Dr. Reddy’s is administered

Do not receive Sugammadex Dr. Reddy’s if:

• you are allergic to sugammadex or to any of the excipients of this medicine (listed in section 6). → Inform your anaesthetist if this applies to you.

Warnings and precautions
Inform your anaesthetist before Sugammadex Dr. Reddy’s is administered if:

• you currently have or have previously had kidney disease. This is important because Sugammadex Dr. Reddy’s is eliminated from the body through the kidneys.
• you currently have or have previously had liver disease.
• you have fluid retention (oedema).
• you have disorders known to increase the risk of bleeding (blood coagulation disorders) or if you are receiving anticoagulant therapy.

Children and adolescents
This medicine is not recommended for children under 2 years of age.
Other medicines and Sugammadex Dr. Reddy’s
→ Inform your anaesthetist if you are taking, have recently taken, or might take any other medicines. Sugammadex Dr. Reddy’s may affect or be affected by other medicines.
Some medicines reduce the effect of Sugammadex Dr. Reddy’s
→ It is particularly important that you inform your anaesthetist if you have recently taken:

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

Sugammadex Dr. Reddy’s may affect hormonal contraceptives

• Sugammadex Dr. Reddy’s may reduce the effectiveness of hormonal contraceptives (including the "Pill", vaginal ring, implant, or hormonal intrauterine system (IUS)), as it reduces the amount of absorbed progestogenic hormone. The amount of progestogen lost when receiving Sugammadex Dr. Reddy’s is approximately equivalent to missing one dose of the contraceptive Pill. → If you need to take the Pill on the same day that you receive Sugammadex Dr. Reddy’s, follow the instructions provided in the Pill’s package leaflet regarding a missed dose. → If you are using other hormonal contraceptives (e.g. a vaginal ring, implant, or IUS), you must use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the instructions provided in the package leaflet.

Effects on blood test results
In general, Sugammadex Dr. Reddy’s has no effect on blood test results. However, it may interfere with test results measuring blood levels of a hormone called progesterone. Please consult your doctor if testing for progesterone levels is required on the same day you receive Sugammadex Dr. Reddy’s.
Pregnancy and breastfeeding
→ Inform your anaesthetist if you are pregnant, might be pregnant, or are breastfeeding. You may still receive Sugammadex Dr. Reddy’s, but this should be discussed with your doctor first. It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to discontinue breastfeeding or to avoid treatment with sugammadex, taking into account the benefits of breastfeeding for the child and the benefits of Sugammadex Dr. Reddy’s for the mother.
Driving and using machines
Sugammadex Dr. Reddy’s has no known influence on the ability to drive vehicles or operate machinery.
Sugammadex Dr. Reddy’s contains sodium
This medicine contains up to 9.7 mg of sodium (a key component of table salt) per ml. This is equivalent to 0.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Sugammadex Dr. Reddy’s is administered

Sugammadex Dr. Reddy’s will be administered to you by the anaesthetist or under the anaesthetist’s supervision.
Dosage
The anaesthetist will determine the appropriate dose of Sugammadex Dr. Reddy’s for you, taking into consideration:

• your body weight
• the extent to which the muscle relaxant is still affecting you.

The usual dose is 2–4 mg per kg of body weight. A dose of 16 mg/kg may be used in adults if rapid reversal of muscle relaxation is required.
The dose of Sugammadex Dr. Reddy’s in children is 2 mg/kg (children and adolescents between 2 and 17 years of age).
How Sugammadex Dr. Reddy’s is administered
Sugammadex Dr. Reddy’s will be administered to you by the anaesthetist as a single intravenous injection.
If you are given more Sugammadex Dr. Reddy’s than recommended
Since your condition will be closely monitored by the anaesthetist, it is unlikely that you will receive an excessive amount of Sugammadex Dr. Reddy’s. However, if this were to happen, it is unlikely to cause you problems.
If you have any doubts about the use of this medicine, consult your anaesthetist or doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If such side effects occur during anaesthesia, they will be detected and treated by the anaesthetist.

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

• Cough.
• Breathing difficulties which may include coughing or movements as if waking up or gasping for breath.
• Light anaesthesia – you may start to come out of deep sleep, and therefore may need additional anaesthetic. This could cause the patient to move or cough at the end of the operation.
• Complications during the procedure such as changes in heart rate, coughing or movements.
• Decrease in blood pressure due to the surgical procedure.

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

• In patients with a history of lung problems, shortness of breath due to muscle contractions of the airways (bronchospasm) has been observed.
• Allergic reactions (hypersensitivity to the drug), such as skin rash, red skin, swelling of the tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, which sometimes can lead to severe drops in blood pressure. Severe allergic or anaphylactoid reactions can be life-threatening. Allergic reactions have been reported more commonly in healthy, awake volunteers.
• Return of muscle relaxation after surgery.

Frequency not known

• When Sugammadex Dr. Reddy’s is administered, severe slowing of the heart and slowing of the heart leading to cardiac arrest may occur.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, consult your anaesthetist or doctor. You can also report side effects directly via the national reporting system at https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse . Reporting side effects can help provide more information on the safety of this medicine.

5. How to store Sugammadex Dr. Reddy’s

Storage will be handled by healthcare professionals.
Keep this medicine out of the 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 that month.
Do not freeze. Keep the vial in the outer carton to protect the medicine from light.
After first opening and dilution, store at 2–8°C and use within 24 hours.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Sugammadex Dr. Reddy’s contains

• The active substance is sugammadex. 1 ml of injectable solution contains 100 mg of sugammadex (as sodium sugammadex). Each 2 ml vial contains 200 mg of sugammadex (as sodium sugammadex). Each 5 ml vial contains 500 mg of sugammadex (as sodium sugammadex). The other components are water for injections and for pH adjustment: sodium hydroxide 0.04% and hydrochloric acid 0.3%.
  Description of the appearance of Sugammadex Dr. Reddy’s and contents of the pack
  Sugammadex Dr. Reddy’s is a clear, colourless to pale yellow injectable solution.

Packs:
1 vial of 2 ml
10 vials of 2 ml
1 vial of 5 ml
10 vials of 5 ml
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Dr. Reddy’s S.r.l.
Piazza Santa Maria Beltrade 1,
20123 Milan
Italy

Manufacturer
betapharm Arzneimittel GmbH,
Kobelweg 95,
86156 Augsburg,
Germany
Dr. Reddy's Laboratories Romania S.R.L.
Strada Caramfil Nicolae 71-73
Floor 5, Space 10
Sector 1
014142 Bucharest
Romania

This medicinal product is authorised in the European Economic Area Member States with the following names: