SUGAMMADEX ORION 100 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Sugammadex Orion 100 mg/ml Solution for Injection EFG

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 (anesthetist) or your 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 Package Leaflet

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

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

What is Sugammadex Orion

Sugammadex Orion contains the active substance sugammadex. Sugammadex Orion is considered a Selective Relaxant Binding Agentas it only works with specific muscle relaxants, namely rocuronium bromide or vecuronium bromide.

What Sugammadex Orion is used for

If you need to undergo surgery, your muscles must be completely relaxed, making it easier for the surgeon to perform the operation. For this, you will be given medications during general anesthesia to relax your muscles. These are called muscle relaxants, such as 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 the recovery of your muscles after surgery so that you can breathe on your own again sooner. It does this by binding to rocuronium bromide or vecuronium bromide in your body. It can be used in adults when rocuronium bromide or vecuronium bromide is used.

It can also be used in newborns, infants, children, and adolescents (from birth to 17 years) when rocuronium bromide is used.

2. What you need to know before you start using Sugammadex Orion

You must not be given Sugammadex Orion

• 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

Consult your anesthesiologist before starting treatment with Sugammadex

• if you have kidney disease or have had it in the past. This is important because Sugammadex is eliminated from your body by the kidneys.
• if you have liver disease or have had it before
• if you have fluid retention (edema)
• if you have a condition that increases the risk of bleeding (coagulation disorders) or are taking anticoagulant medication.

Other medicines and Sugammadex Orion

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 Orion

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

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

Sugammadex Orion may affect hormonal contraceptives

• Sugammadex may make hormonal contraceptives - such as the "Pill", vaginal ring, implants, or an Intrauterine Hormonal Device (IUD-h) - 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 birth control pill.

→ If you are taking the Pillon the same day that you are given Sugammadex, follow the instructions for missing a pill in the pill leaflet.

→ If you are using otherhormonal contraceptives (e.g., a vaginal ring, an implant, or an IUD-h), you should use a non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the recommendations in the 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. Consult your doctor if your progesterone levels need to be analyzed on the same day you receive Sugammadex.

Pregnancy and breastfeeding

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

Sugammadex may still be given to you, but it needs to be discussed beforehand. It is not known whether sugammadex passes into breast milk. Your anesthesiologist will help you decide whether to interrupt breastfeeding or avoid treatment with sugammadex, considering the benefit of breastfeeding to the baby and the benefit of Sugammadex to the mother.

Driving and using machines

Sugammadex has no known influence on your ability to drive and use machines.

Sugammadex Orion contains sodium

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

3. How Sugammadex Orion is administered

Sugammadex will be administered 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 to 4 mg per kg of body weight for patients of any age. A dose of 16 mg/kg may be used in adults if urgent recovery from muscle relaxation is needed.

How Sugammadex Orion is administered

Sugammadex will be administered to you by your anesthesiologist. It is injected once into a vein.

If you are given too much Sugammadex Orion

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 any problems.

If you have any further questions on 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 (may affect up to 1 in 10 people):

• cough
• respiratory difficulties that may include coughing 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, coughing, or movement
• decrease in blood pressure due to the surgical procedure.

Uncommon (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 the medicine) – such as skin rash, skin redness, swelling of your tongue and/or pharynx, difficulty breathing, changes in blood pressure or heart rate, which can sometimes result in a severe drop in blood pressure. Allergic reactions can be life-threatening. Allergic reactions were reported more frequently in healthy, conscious volunteers.
• reappearance of muscle relaxation after surgery.

Rare (cannot be estimated from the available data):

• 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 pharmacist, 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 Orion

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 after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Do not freeze.

Keep the vial in the outer packaging to protect it from light.

After opening and dilution, store at 2-8 °C and use within 24 hours.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Contents of the pack and further information

Composition of Sugammadex Orion

• 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 hydrochloric acid, sodium hydroxide, and water for injections.

Appearance and packaging

Clear, colorless to slightly yellowish solution, free from visible particles.

It is available in:

1 vial of 2 ml, 10 vials of 2 ml

1 vial of 5 ml, 10 vials of 5 ml.

Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Orion Corporation

Orionintie 1

FI-02200 Espoo

Finland

Manufacturer

Orion Corporation

Orion Pharma

Orionintie 1

FI-02200 Espoo

Finland

Orion Corporation

Orion Pharma

Joensuunkatu 7

FI-24100 Salo

Finland

You can request more information about this medicine from the local representative of the marketing authorization holder:

Orion Pharma, S.L.

Avda. Alberto Alcocer 46B

28016 – Madrid

Spain

Phone: +349 159 9 86 01

Date of last revision of this leaflet:05/2025

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/)