Sugammadex Mylan

What it is for

Some medicines reduce the effect of Sugammadex Mylan It is especially important that you tell your anaesthetist if you have recently taken:

• What Sugammadex Mylan is Sugammadex Mylan contains the active substance sugammadex. Sugammadex Mylan is considered to be a selective relaxant binding agent since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.
• What Sugammadex Mylan 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 Mylan 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 Mylan is given You should not be given Sugammadex Mylan
• • 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 Mylan is given
• • if you have kidney disease or had in the past. This is important as sugammadex 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 Mylan Tell your anaesthetist if you are taking, have recently taken or might take any other medicines.
• Sugammadex Mylan may affect other medicines or be affected by them.
• • toremifene (used to treat breast cancer).
• • fusidic acid (an antibiotic).
• Sugammadex Mylan can affect hormonal contraceptives Sugammadex Mylan 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 Mylan is about the same as missing one oral contraceptive Pill.
• • If you are taking the Pill on the same day as Sugammadex Mylan 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 Mylan 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 Mylan 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 Mylan, 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 Sugamadex Mylan to the mother.
• Driving and using machines Sugammadex Mylan has no known influence on your ability to drive and use machines.
• Sugammadex Mylan contains sodium This medicine contains up to 9.2 mg sodium (main component of cooking / table salt) in each mL.
• This is equivalent to 0.5 % of the recommended maximum daily dietary intake of sodium for an adult.

From the package leaflet in EMA’s product information, p. 28–29 · 2026-06-12