Sugammadex Aspen

Package leaflet: Information for the user

Sugammadex Aspen 100 mg/mL solution for injection

sugammadex
Please read this leaflet carefully before this medicine is given 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, please tell your doctor or anaesthetist. See section 4.

Contents of this leaflet

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

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

What Sugammadex Aspen is
Sugammadex Aspen contains the active substance sugammadex. Sugammadex is considered a
Selective Relaxant Binding Agent because it selectively binds only to specific muscle-relaxing
medicines, rocuronium bromide or vecuronium bromide.
What Sugammadex Aspen is used for
During certain types of surgery, muscles need to be completely relaxed. This makes the surgeon's
task easier. To achieve this, general anaesthesia includes medicines that relax the muscles. 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 Aspen is used to speed up muscle recovery after surgery, allowing you to breathe
on your own again as quickly 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 muscle relaxation.

2. What you should know before Sugammadex Aspen is administered

Do not be given Sugammadex Aspen

• 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 Aspen is administered

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

• Sugammadex Aspen may reduce the effectiveness of hormonal contraceptives (including oral contraceptive pills, vaginal ring, implant, or intrauterine hormonal system, IUS), as it reduces the amount of progestogenic hormone you are receiving. The amount of progestogen lost when taking Sugammadex Aspen is approximately equivalent to missing one dose of the contraceptive pill. → If you need to take the oral contraceptive pill on the same day you are given Sugammadex Aspen, 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 tests
In general, Sugammadex Aspen has no effect on blood tests. However, it may affect blood test results for progesterone. Please consult your doctor if testing for progesterone levels is required on the same day you receive Sugammadex Aspen.
Pregnancy and breastfeeding
→ Inform your anaesthetist if you are pregnant or might be pregnant, or if you are breastfeeding.
You may still receive Sugammadex Aspen, 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 to refrain from treatment with sugammadex, taking into account the benefits of breastfeeding for the child and the benefits of Sugammadex Aspen for the mother.
Driving and using machines
Sugammadex Aspen has no known influence on the ability to drive vehicles or use machinery.
Sugammadex Aspen contains sodium
This medicine contains up to 9.5 mg of sodium (a key component of table salt) per mL. This corresponds to 0.5% of the maximum daily recommended intake of sodium for an adult.

3. How Sugammadex Aspen is administered

Sugammadex Aspen will be administered to you by the anaesthetist or under the anaesthetist's supervision.
The dose
The anaesthetist will calculate the appropriate dose of Sugammadex Aspen for you, taking into consideration:

• your body weight
• the extent to which the muscle relaxant is still acting on 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 muscle relaxation is required.
How Sugammadex Aspen is administered
Sugammadex Aspen will be administered by the anaesthetist. It is given as a single intravenous injection.
If you are given more Sugammadex Aspen than recommended
Since your condition will be closely monitored by the anaesthetist, it is unlikely that you will receive an excessive amount of Sugammadex Aspen. 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 experiences 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 resembling waking up or gasping for breath
• Light anaesthesia – you may begin to come out of deep sleep and therefore may require additional anaesthetic. This may cause you 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, 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, awake volunteers
• Return of muscle relaxation after surgery

Frequency not known

• When Sugammadex Aspen is administered, severe slowing of the heart and slowing of the heart to the point of cardiac arrest may occur.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, speak to your doctor or anaesthetist. You can also report side effects directly via
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 Aspen

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 on the label of the
vial after Exp. The expiry date refers to the last day of that month.
Do not store above 30°C. Do not freeze. Keep the vial in the outer packaging to protect the
medicine from light.
After first opening and dilution, chemical and physical in-use stability has been demonstrated
for 48 hours at a temperature of 2–25°C. From a microbiological standpoint, the diluted product
should be used immediately. If not used immediately, the storage times during use and
conditions prior to use are the responsibility of the user and should normally not exceed
24 hours at a temperature between 2°C and 8°C, unless the dilution was carried out under
controlled and validated aseptic conditions.
Do not use this medicine if you notice any visible signs of deterioration.

6. Package contents and other information

What Sugammadex Aspen 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 Aspen and contents of the pack
Sugammadex Aspen is a clear, colourless to slightly yellow/brown injectable solution, free from visible particles.
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
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
24 Dublin, Ireland
Tel: +39 0687 502 429

Manufacturer
PHARMIDEA
4 Rupnicu Street
Olaine, Olaine district, LV-2114
Latvia
COMBINO PHARM MALTA LTD
HF-60, Hal Far Industrial Estate
Hal Far BBG 3000
Malta
MEDICHEM S.A.
Narcís Monturiol 41A
08970 Sant Joan Despí - Barcelona
Spain

The following information is intended for healthcare professionals only:
For more detailed information, refer to the Summary of Product Characteristics (SmPC) of Sugammadex Aspen