Sugammadex Mylan - patient leaflet, side effects, dosage

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

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 and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used for a moderate level of relaxation.

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.

Children and adolescents

This medicine is not recommended for infants less than 2 years of age.

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.

Some medicines reduce the effect of Sugammadex Mylan

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 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.

• 3. How Sugammadex Mylan is given

Sugammadex Mylan 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 Mylan 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. A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.

The dose of Sugammadex Mylan for children is 2 mg/kg (children and adolescents between 2–17 years old).

How Sugammadex Mylan is given

Sugammadex Mylan will be given to you by your anaesthetist. It is given as a single injection through an intravenous line.

If more Sugammadex Mylan 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 Mylan. 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 Mylan is administered.

Reporting of side effects

If you get any side effects, talk to your anaesthetist or your doctor This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in By reporting side effects you can help provide more information on the safety of this medicine.

5. How to store Sugammadex Mylan

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.

Store below 30°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.

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

6. Contents of the pack and other information

What Sugammadex 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 and/or sodium hydroxide.

What Sugammadex looks like and contents of the pack

Sugammadex Mylan is a clear and colourless to slightly yellow solution for injection. It comes in four different pack sizes, containing either 1 or 10 vials with 2 mL or 1 or 10 vials with 5 mL solution for injection

Not all pack sizes may be marketed.

Marketing Authorisation Holder

Mylan Ireland Limited

Unit 35/36

Grange Parade

Baldoyle Industrial Estate

Dublin 13

Ireland

Manufacturer

Mylan SAS

117 Allée des Parcs

69800 Saint-Priest

France

Wessling Hungary Ltd

Anonymous u. 6

1045 Budapest

Hungary

Mylan Germany GmbH

Benzstrasse 1

Bad Homburg

61352 Hesse

Germany

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

België/Belgiqu­e/Belgien Mylan bv / srl	Lietuva Mylan Healthcare UAB
Tél/Tel: + 32 (0)2 658 61 00	Tel: +370 5 205 1288
Efc^rapufl Maw.iaH EOO4	Luxembourg/Lu­xemburg Mylan bv / srl
Ten: +359 2 44 55 400	Tel: + 32 (0)2 658 61 00 (Belgique/Belgien)

Česká republika

Mylan Healthcare CZ s.r.o.

Tel: + 420 222 004 400

Danmark

Viatris ApS

Tlf: +45 28 11 69 32

Deutschland

Mylan Healthcare GmbH

Tel: +49 800 0700 800

Eesti

BGP Products Switzerland GmbH Eesti filiaal

Tel: + 372 6363 052

EÀÀàôa

Generics Pharma Hellas EnE

Tql: +30 210 993 6410

España

Mylan Pharmaceuticals, S.L

Tel: + 34 900 102 712

France

Mylan S.A.S

Tel: +33 4 37 25 75 00

Hrvatska

Mylan Hrvatska d.o.o.

Tel: +385 1 23 50 599

Ireland

Mylan Ireland Limited

Tel: +353 1 8711600

Ísland

Icepharma hf

Símí: +354 540 8000

Italia

Mylan Italia S.r.l.

Tel: + 39 02 612 46921

Kùnpoç

Varnavas Hadjipanayis Ltd

Tql: +357 2220 7700

Latvija

Mylan Healthcare SIA

Tel: +371 676 055 80

This leaflet was last revised in

Detailed information on this medicine is available on the European Medicines Agency web site: http : //www.ema.euro­pa.eu

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The following information is intended for healthcare professionals only:

For detailed information refer to the Summary of Product Characteristics of Sugammadex Mylan

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