Sugammadex aspen

Patient Information Leaflet

Sugammadex Aspen, 100 mg/mL, solution for injection
Sugammadexum
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for you.

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

Leaflet Contents

1. What Sugammadex Aspen is and what it is used for
2. Important information before Sugammadex Aspen is administered
3. How Sugammadex Aspen is administered
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 acts only on specific muscle relaxants – rocuronium bromide or vecuronium bromide.

Why Sugammadex Aspen is used
During certain types of surgery, a patient's muscles must be completely relaxed. This allows the surgeon to perform the procedure more easily. For this purpose, muscle relaxants are administered during general anaesthesia. These are known as neuromuscular blocking agents, and include rocuronium bromide and vecuronium bromide.
Since these drugs also relax the respiratory muscles, assisted ventilation (artificial respiration) is required during and after surgery until the patient regains the ability to breathe independently.

Sugammadex Aspen is used to accelerate the return of normal muscle function after surgery, enabling the patient to breathe spontaneously earlier. It works by binding to rocuronium bromide or vecuronium bromide in the body.
The medicine can be used in adults when rocuronium bromide or vecuronium bromide has been administered, and also in children and adolescents (aged 2 to 17 years) when rocuronium bromide has been given to achieve moderate to profound muscle relaxation.

2. Important information before using Sugammadex Aspen

When not to use Sugammadex Aspen

• if the patient is allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6). → In such a case, the anaesthesiologist must be informed.

Warnings and precautions
Before administration of Sugammadex Aspen, discuss with the anaesthesiologist if:

• the patient currently has or has had kidney disease in the past. This is important because Sugammadex Aspen is eliminated from the body via the kidneys.
• the patient currently has or has had liver disease.
• the patient has fluid retention in the body (oedema).
• the patient has diseases known to increase the risk of bleeding (coagulation disorders) or is taking anticoagulant medicines.

Children and adolescents
Use of this medicine is not recommended in children under 2 years of age.
Sugammadex Aspen and other medicines
→ Inform the anaesthesiologist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Sugammadex Aspen may affect the action of other medicines, or other medicines may affect the action of Sugammadex Aspen.
Some medicines reduce the effectiveness of Sugammadex Aspen
→ It is particularly important to inform the anaesthesiologist if the patient has recently taken:

• toremifene (used in the treatment of breast cancer)
• fusidic acid (an antibiotic).

Sugammadex Aspen may affect the effectiveness of hormonal contraceptives

• Sugammadex Aspen may reduce the effectiveness of hormonal contraceptives, including oral contraceptive pills, vaginal ring, implant, or transdermal therapeutic system releasing progestagen (hormonal intrauterine device), because it reduces the amount of hormone delivered. The amount of progestagen lost due to administration of Sugammadex Aspen is approximately equivalent to missing one oral contraceptive pill. → In case of taking an oral contraceptive pill on the same day as Sugammadex Aspen is administered, follow the instructions for missed pill provided in the package leaflet of the hormonal contraceptive. → In case of using other hormonal contraceptives (such as vaginal ring, implant, or hormonal intrauterine device), an additional non-hormonal contraceptive method (e.g. condoms) should be used for the next 7 days, and the recommendations in the contraceptive's package leaflet should be followed.

Effect on blood test results
Generally, Sugammadex Aspen does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Please consult a doctor if progesterone blood levels need to be tested on the same day as administration of Sugammadex Aspen.
Pregnancy and breastfeeding
→ If the patient is pregnant, suspects she may be pregnant, or is breastfeeding, she should inform the anaesthesiologist.
Sugammadex Aspen may still be used in pregnant patients, but this should first be discussed with the doctor.
It is not known whether sugammadex passes into human milk. The anaesthesiologist will help the patient 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 treatment with Sugammadex Aspen for the mother.
Driving and operating machinery
The effect of Sugammadex Aspen on the ability to drive and operate machinery is unknown.
Sugammadex Aspen contains sodium
The medicine contains up to 9.5 mg of sodium (the main component of table salt) per millilitre. This corresponds to 0.5% of the maximum recommended daily dietary intake of sodium for adults.

3. How is Sugammadex Aspen administered

Sugammadex Aspen will be administered to the patient by an anaesthesiologist or under the supervision of an anaesthesiologist.
Dosage
The anaesthesiologist will adjust the dose of Sugammadex Aspen based on:

• the patient's body weight
• the intensity of the muscle relaxant effect in the patient.

The usual dose is 2–4 mg/kg body weight in adults and children and adolescents aged from 2 to 17 years. If rapid reversal of neuromuscular blockade is required urgently, a dose of 16 mg/kg body weight may be used in adults.
How Sugammadex Aspen is administered
Sugammadex Aspen is administered by an anaesthesiologist as a single intravenous injection through an intravenous line.
Administration of a higher than recommended dose of Sugammadex Aspen
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex Aspen is unlikely. Nevertheless, if such an event occurs, no problems are expected to arise.
If you have any further doubts regarding the use of this medicine, please consult the anaesthesiologist or another physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following adverse reactions occur during anaesthesia of the patient, they will be noticed and treated by the anaesthesiologist.

Common adverse reactions (may affect fewer than 1 in 10 people)

• Coughing.
• Breathing difficulties, including coughing or movement, such as during awakening or taking a breath.
• Light anaesthesia – the patient may begin to wake up from deep sleep and therefore may require additional anaesthetic. This may result in movement or coughing towards the end of surgery.
• Complications during the procedure, such as changes in heart rate, coughing or movement.
• Reduced blood pressure associated with the surgical procedure.

Uncommon adverse reactions (may affect fewer than 1 in 100 people)

• Shortness of breath due to bronchial muscle spasm (bronchospasm) in patients with a history of lung disease.
• Allergic reactions (hypersensitivity to the medicine) – such as rash, redness of the skin, swelling of the tongue and (or) throat, shortness of breath, changes in blood pressure or heart rhythm, sometimes leading to severe drop in blood pressure. Severe allergic reactions or allergic-like conditions may be life-threatening. Allergic reactions have been reported more frequently in healthy, awake volunteers.
• Return of muscle weakness after surgery.

Frequency not known

• Following administration of Sugammadex Aspen, severe cases of bradycardia (slow heart rate) may occur, including slowing of the heart rate up to cardiac arrest.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the anaesthesiologist or another doctor. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products:
Al. Jerozolimskie 181 C
02-222 Warsaw
Tel.: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sugammadex Aspen

The medicine will be stored by healthcare personnel.
Keep the medicine out of sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and vial label following:
"EXP". The expiry date refers to the last day of the stated month.
Do not store above 30°C. Do not freeze. Store vials in the outer packaging to protect from light.
After first opening and dilution, chemical and physical stability of the ready-to-use solution has been demonstrated for 48 hours at temperatures from 2°C to 25°C. From a microbiological standpoint, the diluted product should be used immediately. If the medicine is not used immediately, the responsibility for storage conditions and duration prior to use lies with the user and should generally not exceed 24 hours at 2°C to 8°C, unless dilution was carried out under controlled and validated aseptic conditions.
Do not use this medicine if any visible signs of deterioration are observed.

6. Contents of the pack and other information

What Sugammadex Aspen contains

• The active substance is sugammadex. 1 mL of the injection 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.

• Other ingredients are: water for injections, hydrochloric acid and (or) sodium hydroxide.

What Sugammadex Aspen looks like and contents of the pack
Sugammadex Aspen is a clear, colourless to slightly yellowish-brown injection solution, free from visible solid particles.
It is available in two different pack sizes containing either 10 vials of 2 mL or 10 vials of 5 mL of injection solution, packed in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland
Tel: 0048 22 104 21 00

Manufacturer
Pharmidea
4 Rupnicu Street
Olaine, Olaine district, LV-2114
Latvia

Medichem S.A.
Narcís Monturiol 41A
08970 Sant Joan Despí - Barcelona
Spain

Manufacturer/Importer
Combino Pharm Malta Ltd.
HF60 Hal Far Industrial Estate
Hal Far, BBG3000
Malta

Information intended solely for healthcare professionals:

For detailed information, please refer to the Summary of Product Characteristics for Sugammadex Aspen.