SUGAMMADEX ASPEN 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Aspen 100mg/ml solution for injection EFG

sugammadex

Read all of 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 further questions, ask your anesthesiologist or doctor.
• If you experience any side effects, talk to your anesthesiologist or another doctor, even if it is not listed in this leaflet. See section 4.

Contents of the pack

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

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

What isSugammadex Aspen

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

What isSugammadex Aspen used for

If you need to have surgery, your muscles must be completely relaxed, making the operation easier for the surgeon. To achieve this, you will be given medications during general anesthesia to relax your muscles. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Since these medications also block the respiratory muscles, you will need help breathing (artificial respiration) during and after surgery until you can breathe on your own again.

Sugammadex is used to speed up muscle recovery after surgery so that you can breathe on your own again sooner. It does this by combining with rocuronium bromide or vecuronium bromide in your body. It can be used in adults when rocuronium bromide or vecuronium bromide is used, and in children and adolescents (between 2 and 17 years) when rocuronium bromide is used for moderate muscle relaxation.

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

You should not be givenSugammadex Aspen

• If you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).

→ Tell your anesthesiologist if this applies to you.

Warnings and precautions

Talk to your anesthesiologist before starting the administration of sugammadex

• If you have any kidney disease or have had it in the past. This is important because sugammadex is eliminated from the body through the kidneys.
• If you have liver disease or have had it before.
• If you have fluid retention (edema).
• If you have a disease that increases the risk of bleeding (blood coagulation disorders) or are taking anticoagulant medication.

Children and adolescents

This medicine is not recommended for children under 2 years of age.

Other medicines and Sugammadex Aspen

→ Tell your anesthesiologist if you are taking, have recently taken, or might take any other medicines.

Sugammadex may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex Aspen

→ It is especially important that you tell your anesthesiologist if you have recently taken:

• toremifene (used to treat breast cancer);
• fusidic acid (an antibiotic).

Sugammadex Aspen may affect hormonal contraceptives

? Sugammadex may make hormonal contraceptives such as the pill, vaginal ring, implants, or an intrauterine hormonal device (IUD) less effective because it reduces the amount of progestogen that reaches you. The amount of progestogen lost due to the use of sugammadex is approximately the same as when you miss a contraceptive pill.

→ If you are taking the pillon the same day that you are given sugammadex, follow the instructions for missed doses in the pill's package leaflet.

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

Effects on blood tests

In general, sugammadex does not affect laboratory tests. However, it may affect the results of a blood test when progesterone levels are measured. Talk to your doctor if your progesterone levels need to be analyzed on the same day that you receive sugammadex.

Pregnancy and breastfeeding

→ Tell your anesthesiologist if you are pregnant or think you may be pregnant or if you are breastfeeding.

It is possible that you will still be given sugammadex, but it needs to be discussed beforehand.

It is not known whether sugammadex can pass into breast milk. Your anesthesiologist will help you decide whether to interrupt breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding for the baby and the benefit of sugammadex for the mother.

Driving and using machines

Sugammadex has no known influence on the ability to drive and 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 recommended daily sodium intake for an adult.

3. How Sugammadex Aspen is given

Sugammadex will be given to you by your anesthesiologist or under their supervision.

Dose

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

? your weight;

? the amount of muscle relaxant that is still affecting you.

The usual dose is 2-4 mg per kg of body weight for adults, children, and adolescents from 2 to 17 years. A dose of 16 mg/kg can be used in adults if urgent recovery of muscle relaxation is needed.

How Sugammadex Aspen is given

An anesthesiologist will give you sugammadex. It is given as a single injection into a vein.

If you are given more Sugammadex Aspen than recommended

Since your anesthesiologist will be carefully monitoring the situation, it is unlikely that you will be given too much sugammadex. But even if this happens, it is unlikely to cause you any problems.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If these side effects occur while you are under anesthesia, your anesthesiologist will detect and treat them.

Common side effects (may affect up to 1 in 10 people)

• Cough
• Respiratory difficulties that may include cough or movements as if waking up or taking a breath
• Light anesthesia; you may start to wake up, so you may need more anesthetic. This can cause you to move or cough at the end of the operation
• Complications during the procedure, such as changes in heart rate, cough, or movement
• Decrease in blood pressure due to the surgical procedure

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

• Difficulty breathing due to muscle spasms in the airways (bronchospasm) that occur in patients with a history of lung problems
• Allergic reactions (hypersensitivity to medicines) such as, for example, rash, skin redness, swelling of the tongue or pharynx, difficult breathing, changes in blood pressure or heart rate, which can sometimes cause a severe drop in blood pressure. Allergic reactions or severe allergic reactions can be life-threatening

Allergic reactions were reported more frequently in healthy conscious volunteers

• Reappearance of muscle relaxation after surgery

Frequency not known

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

Reporting of side effects

If you experience any side effects, talk to your doctor or anesthesiologist, even if it is not listed in this leaflet. You can also report side effects directly through the Spanish Medicines Agency's website: www.notificaRAM.es By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Sugammadex Aspen

Storage will be 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 which is stated on the carton and on the label of the vial after “EXP”. The expiry date is the last day of the month shown.

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, the chemical and physical stability has been demonstrated for 48 hours between 2°C and 25°C. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and should not normally exceed 24 hours between 2°C and 8°C, unless the dilution has been made in controlled and validated aseptic conditions.

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

6. Contents of the pack and further information

Composition of Sugammadex Aspen

• The active substance is sugammadex.

Each ml of solution for injection contains sugammadex sodium equivalent to 100 mg of sugammadex.

Each 2 ml vial contains sugammadex sodium equivalent to 200 mg of sugammadex.

Each 5 ml vial contains sugammadex sodium equivalent to 500 mg of sugammadex.

• The other ingredients are water for injections, hydrochloric acid, and sodium hydroxide.

Appearance and packaging

Sugammadex Aspen is a clear and colorless to slightly yellow/brown solution for injection without visible particles.

It comes in two different pack sizes, each containing 10 vials of 2 ml or 10 vials of 5 ml of solution for injection.

Not all 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 last revision of this 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/

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This information is intended only for healthcare professionals:

For detailed information, consult the summary of product characteristics of Sugammadex Aspen.