Bridion
sugammadex
sugammadex
Keep this leaflet. You may need to read it again.
If you have further questions, ask your anaesthetist or doctor.
If you get any side effects, talk to your anaesthetist or other doctor. This includes any possible
side effects not listed in this leaflet. See section 4.
What Bridion is and what it is used for
What you need to know before Bridion is given
How Bridion is given
Possible side effects
How to store Bridion
Contents of the pack and other information
Bridion contains the active substance sugammadex. Bridion is considered to be a Selective Relaxant Binding Agent since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.
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.
Bridion 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.
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.
Talk to your anaesthetist before Bridion is given
if you have kidney disease or had in the past. This is important as Bridion 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.
This medicine is not recommended for infants less than 2 years of age.
→ Tell your anaesthetist if you are taking, have recently taken or might take any other medicines. Bridion may affect other medicines or be affected by them.
toremifene (used to treat breast cancer).
fusidic acid (an antibiotic).
Bridion 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 Bridion is about the same as missing one oral contraceptive Pill.
→ If you are taking the Pill on the same day as Bridion 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.
In general, Bridion 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 Bridion.
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 Bridion to the mother.
Bridion has no known influence on your ability to drive and use machines.
This medicine contains up to 9.7 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.
Bridion will be given to you by your anaesthetist, or under the care of your anaesthetist.
Your anaesthetist will work out the dose of Bridion 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 children and adolescents between
2-17 years old. A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.
Bridion will be given to you by your anaesthetist. It is given as a single injection through an intravenous line.
As your anaesthetist will be monitoring your condition carefully, it is unlikely that you will be given too much Bridion. 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.
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.
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
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
Severe slowing of the heart and slowing of the heart up to cardiac arrest may occur when
Bridion is administered
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 national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.
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 to 8°C and use within 24 hours.
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 3.7% and/or sodium hydroxide.
Bridion is a clear and colourless to slightly yellow solution for injection.
It comes in two different pack sizes, containing either 10 vials with 2 mL or 10 vials with 5 mL solution for injection.
Not all pack sizes may be marketed.
Merck Sharp & Dohme B.V.
Waarderweg 39
2031 BN Haarlem The Netherlands
N.V. Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands
For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
MSD Belgium
Tel/Tél: +32(0)27766211
UAB Merck Sharp & Dohme Tel.: +370 5 278 02 47
Мерк Шарп и Доум България ЕООД
Тел.: +359 2 819 3737
MSD Belgium
Tel/Tél: +32(0)27766211
Merck Sharp & Dohme s.r.o. Tel.: +420 233 010 111
MSD Pharma Hungary Kft. Tel.: +36 1 888 5300
MSD Danmark ApS Tlf: +45 4482 4000
Merck Sharp & Dohme Cyprus Limited Tel: 8007 4433 (+356 99917558)
Grünenthal GmbH
Tel: +49 (0) 241 569 1111
Merck Sharp & Dohme B.V.
Tel.: 0800 9999000 (+31 23 5153153)
Merck Sharp & Dohme OÜ Tel: + 372 6144 200
MSD (Norge) AS Tlf: +47 32 20 73 00
MSD Α.Φ.Β.Ε.Ε.
Τηλ: + 30 210 98 97 300
Merck Sharp & Dohme Ges.m.b.H.
Tel: +43 (0) 1 26 044
Merck Sharp & Dohme de España, S.A. Tel: +34 91 321 06 00
MSD Polska Sp. z o.o. Tel.: +48 22 549 51 00
MSD France
Tél: + 33-(0)1 80 46 40 40
Merck Sharp & Dohme, Lda Tel: + 351 21 446 57 00
Merck Sharp & Dohme d.o.o. Tel: + 385 1 6611 333
Merck Sharp & Dohme Romania S.R.L. Tel: + 40 21 529 29 00
Merck Sharp and Dohme Ireland (Human Health) Limited
Tel: +353 (0)1 2998700
Merck Sharp & Dohme, inovativna zdravila d.o.o.
Tel: + 386 1 5204201
Vistor hf.
Sími: +354 535 7000
Merck Sharp & Dohme, s. r. o. Tel: +421 2 58282010
MSD Italia S.r.l.
Tel: +39 06 361911
medicalinformation.it@merck.com
MSD Finland Oy
Puh/Tel: +358 (0) 9 804650
Merck Sharp & Dohme Cyprus Limited
Τηλ: 800 00 673 (+357 22866700)
Merck Sharp & Dohme (Sweden) AB Tel: +46 77 5700488
SIA Merck Sharp & Dohme Latvija Tel: + 371 67 364224
Tel: +353 (0)1 2998700
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For detailed information refer to the Summary of Product Characteristics of BRIDION.