Sugammadex S.A.L.F.

Package leaflet: Information for the user

Sugammadex S.A.L.F. 100 mg/mL solution for injection

Sugammadex
Generic 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, tell your anaesthetist or doctor. See section 4.

Contents of this leaflet

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

1. What Sugammadex S.A.L.F. is and what it is used for

Sugammadex S.A.L.F. contains the active substance sugammadex. Sugammadex is considered a
Selective Relaxant Binding Agent because it binds specifically to certain neuromuscular blocking agents,
namely rocuronium bromide or vecuronium bromide.
What Sugammadex S.A.L.F. is used for
During certain types of surgery, muscles need to be completely relaxed. This makes the surgeon's task easier.
To achieve this, muscle relaxants are added to the general anaesthesia administered. These medicines are
called neuromuscular blocking agents, and include rocuronium bromide and vecuronium bromide. Since
these medicines also relax the muscles controlling 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 S.A.L.F. is used to speed up the recovery of muscle function after surgery, allowing 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
has been administered, and in children and adolescents (aged 2 to 17 years) when rocuronium bromide has
been used to achieve a moderate level of muscle relaxation.

2. What you need to know before Sugammadex S.A.L.F. is administered to you

Do not receive Sugammadex S.A.L.F.

• 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 S.A.L.F. is administered:

• if you currently have or have previously had kidney disease. This is important because Sugammadex S.A.L.F. is eliminated from the body through the kidneys.
• if you currently have or have previously had liver disease.
• if you have fluid retention (oedema).
• if you have conditions known to increase the risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant therapy.

Children and adolescents
This medicine is not recommended for children under 2 years of age.
Other medicines and Sugammadex S.A.L.F.
Inform your anaesthetist if you are taking, have recently taken, or might take any other medicines. Sugammadex S.A.L.F. may affect or be affected by other medicines.
Some medicines reduce the effect of Sugammadex S.A.L.F.
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 S.A.L.F. may affect hormonal contraceptives
Sugammadex S.A.L.F. may reduce the effectiveness of hormonal contraceptives – including oral contraceptive pills, vaginal ring, implant, or hormonal intrauterine system (hormonal IntraUterine System, IUS) – because it reduces the amount of absorbed progestogenic hormone. The amount of progestogen lost when receiving Sugammadex S.A.L.F. is approximately equivalent to that of a missed contraceptive pill dose.
→ If you need to take your oral contraceptive pill on the same day Sugammadex S.A.L.F. is administered, follow the instructions in the contraceptive 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 following 7 days and follow the instructions provided in the package leaflet.
Effects on blood test results
In general, Sugammadex S.A.L.F. does not affect blood test results. However, it may interfere with test results measuring blood levels of a hormone called progesterone. Please consult your doctor if progesterone levels need to be tested on the same day you receive Sugammadex S.A.L.F.
Pregnancy and breastfeeding
Inform your anaesthetist if you are pregnant or could be pregnant, or if you are breastfeeding.
You may still receive Sugammadex S.A.L.F., but you must discuss this with your doctor first.
It is not known whether sugammadex passes into breast milk. Your anaesthetist will help you decide whether to interrupt breastfeeding or to avoid treatment with sugammadex, taking into account the benefits of breastfeeding for the infant and the benefits of Sugammadex S.A.L.F. for the mother.
Driving and using machines
Sugammadex S.A.L.F. has no known influence on the ability to drive or use machinery.
Sugammadex S.A.L.F. contains sodium
This medicine contains up to 9.2 mg of sodium (a component of common salt) per mL.
This is equivalent to 0.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Sugammadex S.A.L.F. is administered

Sugammadex S.A.L.F. will be administered to you by an anaesthetist, or under the supervision of an anaesthetist.
Dosage
The anaesthetist will determine the appropriate dose of Sugammadex S.A.L.F. for you, taking into consideration:

• your body weight
• the extent to which the neuromuscular blocking agent is still affecting you.

The usual dose is 2–4 mg per kg of body weight in adults and in children and adolescents aged between 2 and 17 years. A dose of 16 mg/kg may be used in adults if rapid reversal of neuromuscular blockade is required.
How Sugammadex S.A.L.F. is administered
Sugammadex S.A.L.F. will be administered by the anaesthetist as a single intravenous injection.
If you are given more Sugammadex S.A.L.F. than you should
Since your condition will be closely monitored by the anaesthetist, it is unlikely that you will receive an excessive amount of Sugammadex S.A.L.F. However, if this were to happen, it is unlikely to cause you any problems.
If you have any doubts about the use of this medicine, consult the anaesthetist or another 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 begin 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 medicine) – such as skin rash, redness of the skin, swelling of the tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, which sometimes may 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 (frequency cannot be estimated from the available data)
When Sugammadex S.A.L.F. 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 effect, including those not listed in this leaflet, talk to your doctor or anaesthetist. You can also report side effects directly via the national reporting system at: https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex S.A.L.F.

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 carton to protect the medicine from light.
This medicine does not require any special storage temperature.
After first opening and dilution, store at 2°C–8°C and use within 24 hours.

6. Package contents and other information

What Sugammadex S.A.L.F. contains

• The active substance is sugammadex. 1 mL of injectable 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 excipients are water for injections and hydrochloric acid 3.7%.

Description of the appearance of Sugammadex S.A.L.F. and contents of the pack
Sugammadex S.A.L.F. is a clear, colourless to slightly yellow injectable solution.
It is available in two different pack sizes, containing either 5 vials with 2 mL of injectable solution or 5 vials with 5 mL of injectable solution.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Marconi, 2 – 24069 Cenate Sotto (BG) – Italy

Manufacturer
S.A.L.F. S.p.A. Laboratorio Farmacologico – Via Mazzini, 9 – 24069 Cenate Sotto (BG) – Italy

This medicinal product is authorised in the Member States of the European Economic Area and in the United Kingdom (Northern Ireland) under the following names:
Germany: Sugammadex S.A.L.F. 100 mg/ml Injektionslösung
Spain: Sugammadex S.A.L.F. 100 mg/ml solución inyectable
MM/YYYY

The following information is intended for medical professionals only:
For detailed information, refer to the Summary of Product Characteristics for Sugammadex S.A.L.F.