Sugammadex Aspen 100 mg/ml solution for injection EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Sugammadex Aspen 100mg/ml solution for injection EFG

sugammadex

Read the entire leaflet carefully before you are given this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your anaesthetist or doctor.
• If you experience any side effects, consult your anaesthetist or another doctor, even if they are side effects not listed in this leaflet. See section 4.

Leaflet Contents

1. What Sugammadex Aspen is and what it is used for
2. What you need to know before you are given Sugammadex Aspen
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 is Sugammadex Aspen

Sugammadex Aspen contains the active substance sugammadex. Sugammadex is a selective binding agent, as it only works with specific muscle relaxants: rocuronium bromide or vecuronium bromide.

What Sugammadex Aspen is used for

During surgery, your muscles need to be completely relaxed, which makes the procedure easier for the surgeon. For this reason, during general anaesthesia you will be given medicines to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these medicines also block the muscles used for breathing, you will need assistance with breathing (mechanical ventilation) during and after your operation until you can breathe on your own again.

Sugammadex is used to speed up muscle recovery after surgery so that you can breathe independently sooner. It works by binding to rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used, and in children and adolescents (between 2 and 17 years of age) when rocuronium bromide is used for moderate muscle relaxation.

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

Do not receive 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

Talk to your anaesthetist before starting administration of sugammadex if:

• You have or have had kidney disease. This is important because sugammadex is eliminated from the body through the kidneys.
• You have or have previously had liver disease.
• You have fluid retention (edema).
• You have a medical condition that increases your risk of bleeding (blood coagulation disorders) or if you are taking anticoagulant medication.

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 need to take any other medicines.

Sugammadex may affect other medicines or may be affected by them.

Some medicines reduce the effect of Sugammadex Aspen

→ It is especially 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 may reduce the effectiveness of hormonal contraceptives such as the pill, vaginal ring, implants, or hormonal intrauterine device (IUD), because it reduces the amount of progestogen hormone available. The amount of progestogen lost due to sugammadex use is approximately the same as that lost when a contraceptive pill dose is missed.

→ If you take the pill on the same day that sugammadex is administered, follow the missed dose instructions provided in the pill's package leaflet.

→ If you are using other hormonal contraceptives (e.g., vaginal ring, implant, or IUD), you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the product leaflet.

Effects on blood tests

In general, sugammadex does not affect laboratory tests. However, it may affect the results of a blood test measuring levels of the hormone progesterone. Consult your doctor if your progesterone levels need to be tested on the same day you receive sugammadex.

Pregnancy and breastfeeding

→ Inform your anaesthetist if you are pregnant, think you may be pregnant, or are breastfeeding.

You may still be given sugammadex, but this should be discussed beforehand.

It is unknown 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 baby and the benefits of sugammadex for the mother.

Driving and using machines

Sugammadex has no known influence on the ability to drive or use machines.

Sugammadex Aspen contains sodium

This medicine contains up to 9.5 mg of sodium (the main component of table/cooking salt) per ml. This is equivalent to 0.5% of the maximum daily recommended intake of sodium for an adult.

3. How Sugammadex Aspen is administered

Sugammadex will be administered to you by your anaesthetist or under their supervision.

Dosage

Your anaesthetist will calculate the dose of sugammadex you need based on:

- your weight;

- the amount of residual muscle relaxant still affecting you.

The usual dose is 2–4 mg per kg of body weight for adults, 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 Aspen is administered

An anaesthetist will administer sugammadex to you. It is given as a single intravenous injection.

If you are given more Sugammadex Aspen than you should

As your anaesthetist will be carefully monitoring your condition, it is unlikely that you will be given an excessive amount of sugammadex. However, even if this occurs, it is unlikely to cause you any problems.

If you have any further questions about the use of this medicine, ask your anaesthetist or another doctor.

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If these adverse effects occur while you are under the effects of anaesthesia, your anaesthetist will detect and treat them.

Frequent adverse effects (may affect up to 1 in 10 people)

• Cough
• Respiratory tract difficulties which may include coughing or movements as if awake or gasping for breath
• Superficial anaesthesia; you may begin to wake up, so you will require more anaesthetic. This may cause you to move or cough at the end of the operation
• Complications during the procedure such as, for example, changes in heart rate, coughing or movement
• Decrease in blood pressure due to the surgical intervention

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

• Breathing difficulty due to muscle cramps in the airways (bronchospasm), occurring in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medicines) such as, for example, rash, redness of the skin, swelling of the tongue or pharynx, difficult breathing, changes in blood pressure or heart rhythm, which sometimes lead to a serious drop in blood pressure. Allergy-type reactions or severe allergic reactions can be potentially life-threatening

Allergic reactions were reported more frequently in healthy conscious volunteers

• Recurrence of muscle relaxation after surgery

Frequency not known

• When sugammadex is administered, a significant slowing of the heart may occur, which could even lead to cardiac arrest.

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or anaesthetist, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Aspen

Storage is the responsibility of 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 vial label after "EXP". The expiry date refers to the last day of the month indicated.

Do not store above 30 °C. Do not freeze. Keep the vial in the outer packaging to protect it from light.

After first opening and dilution, chemical and physical in-use stability has been demonstrated for 48 hours between 2 °C and 25 °C. From a microbiological standpoint, the diluted product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and generally should not exceed 24 hours between 2 °C and 8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.

Do not use this medicine if you notice any visible signs of deterioration.

6. Contents of the container and other information

Composition of Sugammadex Aspen

• The active substance is sugammadex.

Each 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 sodium hydroxide.

Appearance of the product and contents of the container

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 of 2 ml or 10 vials of 5 ml of injectable solution.

Only certain pack sizes may be marketed.

Marketing Authorisation Holder

Aspen Pharma Trading Limited
3016 Lake Drive
Citywest Business Campus
Dublin 24, Ireland

Local Representative

Aspen Pharmacare España S.L.
Avenida Diagonal, 512
Planta Interior 1, Oficina 4
08006 Barcelona
Spain

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

Date of the most recent revision of this package leaflet: December 2022

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS): http://www.aemps.gob.es/

This information is intended for healthcare professionals only:

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