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Sugammadex 100 mg/ml solution for injection

Active Ingredient:
sugammadex sodium
Company:  
hameln pharma ltd See contact details
ATC code: 
V03AB35
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About Medicine
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Prescription only medicine
Healthcare Professionals (SmPC) Patient Leaflet (PIL)
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The Patient Information Leaflet (PIL) is the leaflet included in the pack with a medicine.
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Last updated on emc: 30 Jan 2026
{pdf} View or print the patient leaflet as PDF

Below is a text only representation of the Patient Information Leaflet (ePIL).

The text only version may be available in large print, Braille or audio CD. For further information call emc accessibility on {phone} 0800 198 5000. The product code(s) for this leaflet is: PL 01502/0112.

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Sugammadex 100 mg/ml solution for injection

Package leaflet: Information for the user

Sugammadex 100 mg/ml solution for injection

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 anaesthetist or doctor.
  • If you get any side effects, talk to your anaesthetist or doctor. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What Sugammadex 100 mg/ml solution for injection is and what it is used for
2. What you need to know before Sugammadex 100 mg/ml solution for injection is given
3. How Sugammadex 100 mg/ml solution for injection is given
4. Possible side effects
5. How to store Sugammadex 100 mg/ml solution for injection
6. Contents of the pack and other information

1. What Sugammadex 100 mg/ml solution for injection is and what it is used for
What Sugammadex 100 mg/ml solution for injection is

Sugammadex 100 mg/ml solution for injection contains the active substance sugammadex. Sugammadex 100 mg/ml solution for injection is considered to be a Selective Relaxant Binding Agent since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex 100 mg/ml solution for injection is used for

When you have some types of operations, your muscles must be completely relaxed. This makes it easier for the surgeon to do the operation. For this, the general anaesthetic you are given includes medicines to make your muscles relax. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again.

Sugammadex 100 mg/ml solution for injection is used to speed up the recovery of your muscles after an operation to allow you to breathe on your own again earlier. It does this by combining with the rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used.

It can be used in newborn babies, infants, toddlers, children and adolescents (birth to 17 years) when rocuronium bromide is used.

2. What you need to know before Sugammadex 100 mg/ml solution for injection is given
You should not be given Sugammadex 100 mg/ml solution for injection
  • if you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).

Tell your anaesthetist if this applies to you.

Warnings and precautions

Talk to your anaesthetist before Sugammadex 100 mg/ml solution for injection is given

  • if you have kidney disease or had in the past. This is important as Sugammadex 100 mg/ml solution for injection is removed from your body by the kidneys.
  • if you have liver disease or have had it in the past.
  • if you have fluid retention (oedema).
  • if you have diseases which are known to give an increased risk of bleeding (disturbances of blood clotting) or anticoagulation medication.

Other medicines and Sugammadex 100 mg/ml solution for injection

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

Sugammadex 100 mg/ml solution for injection may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex 100 mg/ml solution for injection

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

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

Sugammadex 100 mg/ml solution for injection can affect hormonal contraceptives

Sugammadex 100 mg/ml solution for injection can make hormonal contraceptives - including the ‘Pill’, vaginal ring, implants or a hormonal IntraUterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone. The amount of progestogen lost by using Sugammadex 100 mg/ml solution for injection is about the same as missing one oral contraceptive Pill.

  • If you are taking the Pill on the same day as Sugammadex 100 mg/ml solution for injection is given to you, follow the instructions for a missed dose in the Pill’s package leaflet.
  • If you are using other hormonal contraceptives (for example 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 advice in the package leaflet.

Effects on blood tests

In general, Sugammadex 100 mg/ml solution for injection does not have an effect on laboratory tests. However, it may affect the results of a blood test for a hormone called progesterone. Talk to your doctor if your progesterone levels need to be tested on the same day you receive Sugammadex 100 mg/ml solution for injection.

Pregnancy and breast-feeding

Tell your anaesthetist if you are pregnant or might be pregnant or if you are breast-feeding. You may still be given Sugammadex 100 mg/ml solution for injection, but you need to discuss it first.

It is not known whether sugammadex can pass into breast milk. Your anaesthetist will help you decide whether to stop breast-feeding, or whether to abstain from sugammadex therapy, considering the benefit of breast-feeding to the baby and the benefit of Sugammadex 100 mg/ml solution for injection to the mother.

Driving and using machines

Sugammadex 100 mg/ml solution for injection has no known influence on your ability to drive and use machines.

Sugammadex 100 mg/ml solution for injection contains sodium

This medicine contains up to 9.7 mg sodium (main component of cooking/table salt) in each millilitre.

This is equivalent to 0.5 % of the recommended maximum daily dietary intake of sodium for an adult.

3. How Sugammadex 100 mg/ml solution for injection is given

Sugammadex 100 mg/ml solution for injection will be given to you by your anaesthetist, or under the care of your anaesthetist.

The dose

Your anaesthetist will work out the dose of Sugammadex 100 mg/ml solution for injection you need based on:

  • your weight
  • how much the muscle relaxant medicine is still affecting you.

The usual dose is 2-4 mg per kg body weight for adults and for patients of any age. A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.

How Sugammadex 100 mg/ml solution for injection is given

Sugammadex 100 mg/ml solution for injection will be given to you by your anaesthetist. It is given as a single injection through an intravenous line.

If more Sugammadex 100 mg/ml solution for injection is given to you than recommended

As your anaesthetist will be monitoring your condition carefully, it is unlikely that you will be given too much Sugammadex 100 mg/ml solution for injection. 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 anaesthetist or other 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 anaesthesia, they will be seen and treated by your anaesthetist.

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

  • Cough
  • Airway difficulties that may include coughing or moving as if you are waking or taking a breath
  • Light anaesthesia - you may start to come out of deep sleep, so need more anaesthesia. This might cause you to move or cough at the end of the operation
  • Complications during your procedure such as changes in heart rate, coughing or moving
  • Decreased blood pressure due to the surgical procedure

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

  • Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in patients with a history of lung problems
  • Allergic (drug hypersensitivity) reactions - such as a rash, red skin, swelling of your tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, sometimes resulting in a serious decrease of blood pressure. Severe allergic or allergic-like reactions can be life threatening.
    Allergic reactions were reported more commonly in healthy, conscious volunteers
  • Return of muscle relaxation after the operation

Frequency not known

  • Severe slowing of the heart and slowing of the heart up to cardiac arrest may occur when Sugammadex 100 mg/ml solution for injection is administered

Reporting of side effects

If you get any side effects, talk to your anaesthetist or other doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme, Website: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sugammadex 100 mg/ml solution for injection

Storage will be handled by 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 refers to the last day of that month.

Keep the vial in the outer carton in order to protect from light.

This medicine does not require any special temperature storage conditions.

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

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

6. Contents of the pack and other information
What Sugammadex 100 mg/ml solution for injection contains
  • The active substance is sugammadex.
    1 ml solution for injection contains sugammadex sodium equivalent to 100 mg sugammadex.
    Each vial of 2 ml contains sugammadex sodium equivalent to 200 mg sugammadex.
    Each vial of 5 ml contains sugammadex sodium equivalent to 500 mg sugammadex.
  • The other ingredients are water for injections, hydrochloric acid (to adjust pH) and/or sodium hydroxide (to adjust pH).

What Sugammadex 100 mg/ml solution for injection looks like and contents of the pack

Sugammadex 100 mg/ml solution for injection is a clear, colourless to slightly yellow brown solution for injection, practically free from particles.

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

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder:

hameln pharma ltd
Nexus
Gloucester Business Park
Gloucester
GL3 4AG
United Kingdom

Manufacturer(s):

Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands

Synthon Hispania S.L.
C/Castelló, n°1
Sant Boi de Llobregat
08830 Barcelona
Spain

hameln rds s.r.o.
Horna 36
90001 Modra
Bratislava
Slovakia

This medicinal product is authorised in the Member States of the EEA under the following names:

The Netherlands Sugammadex hameln 100 mg/ml oplossing voor injectie

Austria Sugammadex-hameln 100 mg/ml Injektionslösung

Germany Sugammadex-hameln 100 mg/ml Injektionslösung

Denmark Sugammadex hameln

Finland Sugammadex hameln 100 mg/ml injektioneste, liuos

Norway Sugammadex hameln

This leaflet was last revised in 08/2025.

xxxx/37/25

hameln pharma ltd
Company image
Address
Nexus, Gloucester Business Park, Gloucester, GL3 4AG, UK
WWW
https://www.hameln-pharma.com
Telephone
+44 (0)1452 621 661
Fax
+44 (0)1452 632 732
Medical Information e-mail
[email protected]