Sugammadex medac

Package leaflet: Information for the user

Sugammadex medac 100 mg/ml solution for injection

sugammadex
Generic medicine
Please read this leaflet carefully before you are given this medicine 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 medac is and what it is used for
2. What you need to know before Sugammadex medac is administered
3. How Sugammadex medac is administered
4. Possible side effects
5. How to store Sugammadex medac
6. Contents of the pack and other information

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

What is Sugammadex medac
Sugammadex medac contains the active substance sugammadex. Sugammadex medac is considered a Selective
Steroid Muscle Relaxant Binding Agent because it selectively binds to specific medicines, rocuronium bromide
or vecuronium bromide, known as muscle relaxants, which relax the muscles.
What is Sugammadex medac used for
During certain types of surgery, muscles need to be completely relaxed. This facilitates the surgeon’s task. To achieve this, muscle-relaxing medicines are added to the general anaesthesia administered. These medicines are called muscle relaxants, 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 medac is used to speed up muscle recovery after surgery, enabling you to breathe independently 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 2 to 17 years) when rocuronium bromide is used for moderate muscle relaxation.

2. What you need to know before Sugammadex medac is administered

Do not receive Sugammadex medac

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

Warnings and precautions
Inform your anaesthetist before Sugammadex medac is administered

• if you have or have previously had kidney disease. This is important because Sugammadex medac is eliminated from the body through the kidneys.
• if you 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 medac
→ Inform your anaesthetist if you are currently taking, have recently taken, or might take any other medicines.
Sugammadex medac may affect or be affected by other medicines.
Some medicines reduce the effect of Sugammadex medac
→ 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 medac may affect hormonal contraceptives

• Sugammadex medac may reduce the effectiveness of hormonal contraceptives – including oral contraceptive pills, vaginal ring, implant, or hormonal intrauterine system (IUS) – because it reduces the amount of absorbed progestogenic hormone. The amount of progestogen lost when receiving Sugammadex medac is approximately equivalent to missing one dose of the oral contraceptive pill. → If you need to take your oral contraceptive pill on the same day that Sugammadex medac 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 should 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 medac has no effect on blood test results. However, it may interfere with the results of a test measuring blood levels of a hormone called progesterone. Please consult your doctor if testing of progesterone levels is required on the same day you receive Sugammadex medac.
Pregnancy and breastfeeding
→ Inform your anaesthetist if you are pregnant, think you might be pregnant, or if you are breastfeeding.
You may still receive Sugammadex medac, 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 stop breastfeeding or to avoid treatment with sugammadex, taking into account the benefits of breastfeeding for the infant and the benefits of Sugammadex medac for the mother.
Driving and using machines
Sugammadex medac has no known influence on the ability to drive or operate machinery.
Sugammadex medac contains sodium
This medicine contains up to 9.7 mg of sodium (a key component of table salt) per ml.
This corresponds to 0.5% of the maximum daily recommended dietary intake of sodium for an adult.

3. How Sugammadex medac is administered

Sugammadex medac will be administered to you by an anaesthetist or under the supervision of an anaesthetist.
The dose
The anaesthetist will determine the appropriate dose of Sugammadex medac 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 urgent reversal of muscle relaxation is required.
The dose of Sugammadex medac in children is 2 mg/kg (in children and adolescents between 2 and 17 years of age).
How Sugammadex medac is administered
Sugammadex medac will be administered by the anaesthetist as a single intravenous injection.
If you are given more Sugammadex medac than recommended
Since your condition will be closely monitored by the anaesthetist, it is unlikely that you will receive an excessive amount of Sugammadex medac. 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 your anaesthetist or doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If these 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 may therefore require additional anaesthetic. This could cause the patient to move or cough at the end of surgery
• 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 airway muscle contractions (bronchospasm) has been observed
• Allergic reactions (hypersensitivity to the medicine), such as skin rash, flushed skin, swelling of the tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, which sometimes may lead to a severe drop in blood pressure. Severe allergic or anaphylactoid reactions can be life-threatening.
• Allergic reactions have been reported more commonly in healthy, conscious volunteers
• Return of muscle relaxation after surgery

Frequency not known

• When Sugammadex medac is administered, severe slowing of the heart rate and slowing progressing to cardiac arrest may occur

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, tell your anaesthetist or doctor.
You can also report side effects directly via the national reporting system at 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 medac
   Storage will be managed by healthcare professionals.

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is 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.
After first opening and dilution, store at 2–8°C protected from light and use within 24 hours.

1. Contents of the pack and other information

What Sugammadex medac 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 other components are water for injections, hydrochloric acid and/or sodium hydroxide.

Description of the appearance of Sugammadex medac and contents of the pack
Sugammadex medac is a clear, colourless to pale yellow-brown injectable solution.
It is available in two different pack sizes, containing either 10 vials with 2 ml of injectable solution or 10 vials with 5 ml of injectable solution.
Not all pack sizes may be marketed.
Marketing Authorisation Holder
medac pharma s.r.l.
Via Viggiano 90
00178 Roma
Italy
Manufacturer
PLIVA Hrvatska d.o.o. (PLIVA Croatia Ltd.)
Prilaz baruna Filipovića 25
Zagreb 10000
Croatia

The following information is intended for healthcare professionals only:

For detailed information, refer to the product characteristics summary of Sugammadex medac.