Sugammadex AdroIQ

Package leaflet: Information for the user

Sugammadex Adroiq 100 mg/mL solution for injection

sugammadex
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 get any side effects, talk to your anaesthetist or doctor. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet

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

2. What you need to know before you are given Sugammadex Adroiq

3. How Sugammadex Adroiq is given

4. Possible side effects

5. How to store Sugammadex Adroiq

6. Contents of the pack and other information

7. What is Sugammadex Adroiq and what it is used for

What is Sugammadex Adroiq
Sugammadex Adroiq contains the active substance sugammadex. Sugammadex is considered a selective relaxant binding agent, as it selectively binds to other medicines, namely rocuronium bromide or vecuronium bromide, known as muscle relaxants, which relax the muscles.

What Sugammadex Adroiq 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-relaxing medicines are added to the general anaesthetic. 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 (artificial ventilation) is required during and after surgery until you are able to breathe on your own again.

Sugammadex Adroiq is used to speed up muscle recovery after surgery, allowing you to breathe independently 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 levels of relaxation.

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

Do not receive Sugammadex Adroiq

• 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 Adroiq is administered to you

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

• Sugammadex Adroiq may reduce the effectiveness of hormonal contraceptives (including oral contraceptive pills, 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 Adroiq is approximately equivalent to missing one dose of the contraceptive pill. → If you need to take your oral contraceptive pill on the same day Sugammadex Adroiq 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 intrauterine system (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 product leaflet.

Effects on blood test results
In general, Sugammadex Adroiq has no effect on blood test results. However, it may
affect the results of a test 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 Adroiq.
Pregnancy and breastfeeding
→ Inform your anaesthetist if you are pregnant, suspect you may be pregnant, or are breastfeeding.
You may still receive Sugammadex Adroiq, 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 discontinue breastfeeding or avoid treatment with sugammadex, taking into account
the benefits of breastfeeding for the infant and the benefits of Sugammadex Adroiq for the mother.
Driving and using machines
Sugammadex Adroiq has no known influence on the ability to drive or operate machinery.
Sugammadex Adroiq contains sodium
This medicine contains up to 9.7 mg of sodium (the main 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 Adroiq is administered

Sugammadex Adroiq 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 Adroiq 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 in adults and in children and adolescents aged 2 to 17 years. A dose of 16 mg/kg may be used in adults if rapid reversal of muscle relaxation is required.

How Sugammadex Adroiq is administered
Sugammadex Adroiq will be administered by the anaesthetist as a single intravenous injection.
If you are given more Sugammadex Adroiq 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 Adroiq. 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 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 therefore may require additional anaesthetic. This could cause movements or coughing at the end of the operation
• Complications during the procedure such as changes in heart rate, coughing or movements
• Decreased blood pressure due to the surgical procedure

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

• Shortness of breath due to muscle contractions in the airways (bronchospasm) in patients with a history of lung problems
• 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 severe drops in blood pressure. Severe allergic or allergic-like 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

• Severe slowing of the heart and slowing of the heart to cardiac arrest when Sugammadex Adroiq is administered.

Reporting of side effects
If you experience any side effects, including those not listed in this leaflet, speak to your anaesthetist or doctor. You can also report side effects directly through the national reporting system detailed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex Adroiq

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 stated on the carton and label after "Exp.". The expiry date refers to the last day of that month.
Store below 30 °C. Do not freeze. Keep the vial in the carton to protect the medicine from light.
After first opening and dilution, store at 2 °C–8 °C and use within 24 hours.

6. Package contents and other information

What Sugammadex Adroiq 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, hydrochloric acid and/or sodium hydroxide (to adjust pH).
• See section 2 “Sugammadex Adroiq contains sodium”.

Description of the appearance of Sugammadex Adroiq and package contents
Sugammadex Adroiq is a clear, colourless to pale yellow 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 and Manufacturer

Marketing Authorisation Holder
Extrovis EU Ltd.
Pátriárka utca 14.
2000, Szentendre
Hungary

Manufacturer
Pharma Pack Hungary Kft
Vasút u. 13, Budaörs
2040 Hungary
Pharma Pack Hungary Kft.
Building B, Raktarvarosi Ut 9,
Torokbalint,
2045 Hungary

For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:

België/Belgique/Belgien Lietuva
Extrovis EU Ltd. Extrovis EU Ltd.
Tél/Tel: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]

България Luxembourg/Luxemburg
Extrovis EU Ltd. Extrovis EU Ltd.
Teл.: +41 41 740 1120 Tél/Tel: +41 41 740 1120
[email protected] [email protected]

Česká republika Magyarország
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel.: +41 41 740 1120
[email protected] [email protected]

Danmark Malta
Mashal Healthcare A/S Extrovis EU Ltd.
Tlf: +45 71 86 37 68 Tel: +41 41 740 1120
[email protected] [email protected]

Deutschland Nederland
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]

Eesti Norge
Extrovis EU Ltd. Mashal Healthcare A/S
Tel: +41 41 740 1120 Tlf: +45 71 86 37 68
[email protected] [email protected]

Ελλάδα Österreich
Extrovis EU Ltd. Extrovis EU Ltd.
Τηλ: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]

España Polska
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel.: +41 41 740 1120
[email protected] [email protected]

France Portugal
Extrovis EU Ltd. Extrovis EU Ltd.
Tél: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]

Hrvatska România
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]

Ireland Slovenija
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]

Ísland Slovenská republika
Extrovis EU Ltd. Extrovis EU Ltd.
Sími: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]

Italia Suomi/Finland
Extrovis EU Ltd. Mashal Healthcare A/S
Tel: +41 41 740 1120 Puh/Tel: +45 71 86 37 68
[email protected] [email protected]

Κύπρος Sverige
Extrovis EU Ltd. Mashal Healthcare A/S
Τηλ: +41 41 740 1120 Tel: +45 71 86 37 68
[email protected] [email protected]

Latvija United Kingdom (Northern Ireland)
Extrovis EU Ltd. Extrovis EU Ltd.
Tel: +41 41 740 1120 Tel: +41 41 740 1120
[email protected] [email protected]

Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu.