100 mg / ml injection solution 
sugammadex

Read all of this leaflet carefully before you start using this medicine. It contains information that is important to you.

  • Save this information, you may need to read it again.
  • If you have any further questions, ask your anesthetist or doctor.
  • If you get any side effects, talk to your anesthetist or another doctor. This also applies to any side effects not mentioned in this information. See section 4.

In this leaflet: 
1. What Bridion is and what it is used for 
2. What you need to know before you use Bridion 
3. How Bridion is given 
4. Possible side effects 
5. How to store Bridion 
6. Contents of the packaging and other information 

1. What Bridion is and what it is used for

What Bridion is

Bridion contains the active substance sugammadex. Bridion is considered a selective reversing agent as it only works with specific muscle relaxants, rocuronium bromide and vecuronium bromide

What Bridion is used for

When undergoing certain types of surgeries, the muscles must be completely relaxed. This makes it easier for the surgeon to operate. For this reason, it contains the general anesthesia that you are given drugs that make the muscles relax. These are called muscle relaxants and include e.g. rocuronium bromide and vecuronium bromide. As these medicines also relax your respiratory muscles, you will need help to breathe (artificial respiration) during and after the operation until you can breathe again.

Bridion is used to speed up the recovery of your muscles after an operation so that you can breathe again more quickly. It does this by binding to rocuronium bromide or vecuronium bromide in your body. It can be used by adults when rocuronium bromide or vecuronium bromide is used and by 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 you use Bridion

Do not use Bridion

  • if you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6).

→ Tell your anesthetist if this applies to you.

Warnings and cautions

Talk to an anesthetist before using Bridion

  • if you have or have had kidney disease. This is important because Bridion disappears from your body through the kidneys.
  • if you have or have had liver disease.
  • if you have fluid retention ( edema ).
  • if you have any disease that is known to increase the risk of bleeding (coagulation disorders) or if you are given blood thinners.

Children and young people

This medicine is not recommended for children under 2 years.

Other medicines and Bridion

→ Tell your anesthetist if you are taking, have recently taken or might take any other medicines. Bridion may affect or be affected by other medicines.

Some medicines reduce the effect of Bridion

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

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

Bridion may affect hormonal contraceptives

  • Bridion can make hormonal contraceptives – such as birth control pills, vaginal rings, implants, or IUDs – less effective, as it reduces the amount of the progestogen hormone. The amount of progestogen you lose is roughly equivalent to a forgotten tablet.

→ If you are taking a pill on the same day as you receive Bridion, follow the advice given for a forgotten tablet in the package leaflet for the pill.

→ If you are using any other hormonal contraceptive (eg a vaginal ring, implant, or IUD), you should use an additional non-hormonal contraceptive (eg a condom) for the next 7 days and follow the advice given in the package leaflet.

Effect on blood tests

In general, Bridion does not affect laboratory tests. However, it can affect the results of blood tests for a hormone called progestogen . Tell your doctor if your progestogen levels need to be checked the day you receive Bridion.

Pregnancy and breastfeeding

→ Tell your anesthetist if you are or may be pregnant or if you are breast-feeding.

You may still get Bridion, but you should discuss it first.

It is unknown whether sugammadex is excreted in human milk. Your anesthetist will help you decide whether to discontinue breast-feeding or refrain from treatment with sugammadex after taking into account the benefit of breast-feeding to your baby and the benefit of Bridion to your mother.

Driving and using machines

Bridion has no known effect on your ability to drive or use machines.

Bridion contains sodium

This medicine contains up to 9.7 mg sodium (the main ingredient in table salt / table salt) per milliliter. This corresponds to 0.5% of the maximum recommended daily sodium intake for adults.

3. How Bridion is given

Bridion will be given by an anesthetist, or under the supervision of an anesthetist.

Dos en

Your anesthetist will calculate the dose of Bridion you need based on:

  • your weight.
  • how much the muscle relaxant drug still affects you.

The usual dose is 2-4 mg per kg body weight. A dose of 16 mg / kg can be used in adults if a faster recovery from muscle relaxation is needed.

Bridione dose one for children is 2 mg / kg (children and adolescents between 2-17 years).

How Bridion is given

Bridion will be given to you by your anesthetist. It is given as a single injection via an intravenous infarction.

If you use more Bridion than you should

Because your anesthesiologist will monitor your condition closely, you are unlikely to receive too much Bridion. Even if it did, it is unlikely to lead to any problems.

If you have any further questions on the use of this product, ask your anesthetist 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 anesthetized, they will be noticed and treated by your anesthesiologist.

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

  • Cough
  • Respiratory problems that may include coughing or movements such as waking up or taking a breath
  • Mild anesthesia – you may start to wake up from your deep sleep and need more anesthesia . This may cause you to move or cough at the end of the operation
  • Complications during treatment such as changes in heart rate, cough, or movements
  • Decreased blood pressure due to the surgery

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

  • Shortness of breath caused by muscle spasms in the airways ( bronchospasm ), occurred in patients with a history of lung problems
  • Allergic reactions (drug hypersensitivity) – such as skin rash, redness of the skin, swelling of your tongue and/or throat, shortness of breath, changes in blood pressure or heart rhythm, which sometimes lead to a severe drop in blood pressure. Severe allergic or allergy-like reactions that can be life-threatening. Allergic reactions were reported more frequently in healthy subjects who were conscious
  • Return of muscle relaxation after surgery

Side effects are with no known frequency

  • Severe cardiac arrest and cardiac arrest to cardiac arrest may occur when Bridion is given

Reporting of side effects

If you get any side effects, talk to your doctor, pharmacist, or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly to the Medical Products Agency, www.lakemedelsverket.se. By reporting side effects, you can help increase drug safety information

5. How to store Bridion

The storage is handled by the medical staff.

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 label after “EXP”. The expiration date is the last day of the specified month.

Do not store above 30 ° C. Do not freeze. Store the vials in the outer carton. Sensitive to light.

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

6. Contents of the packaging and other information

Content declaration

  • 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 corresponding to 200 mg sugammadex. 
    Each vial of 5 ml contains sugammadex equivalent to 500 mg sugammadex.
  • The other ingredients are water for injections, hydrochloric acid 3.7% and / or sodium hydroxide.

What the medicine looks like and the contents of the pack

Bridion is a clear and colorless to slightly yellow solution for injection .

It is available in two different packs, containing either 10 vials of 2 ml or 10 vials of 5 ml solution for injection .

Not all pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorisation Holder

Merck Sharp & Dohme BV

Waarderweg 39

2031 BN Haarlem

Netherlands

Manufacturer

  • NV Organon, Kloosterstraat 6, 5349 AB Oss, The Netherlands

Contact the representative of the marketing authorization holder to find out more about this medicine:

Belgium / Belgique / BelgienMSD Belgium BVBA / SPRLTel / Tel: +32 (0) 27766211dpoc_belux@merck.com LithuaniaUAB Merck Sharp & DohmeTel .: +370 5 278 02 47msd_lietuva@merck.com
BulgariaMark Harp and Doom Bulgaria BulgariaTel: +359 2 819 3737info-msdbg@merck.com Luxembourg / LuxemburgMSD Belgium BVBA / SPRLTel / Tel: +32 (0) 27766211dpoc_belux@merck.com
Czech RepublicMerck Sharp & Dohme sroTel .: +420 233 010 111dpoc_czechslovak@merck.com HungaryMSD Pharma Hungary Kft.Tel .: +36 1 888 5300hungary_msd@merck.com
DenmarkMSD Danmark ApSTel: +45 4482 4000dkmail@merck.com MaltaMerck Sharp & Dohme Cyprus LimitedTel: 8007 4433 (+356 99917558)malta _ info @ merck com
GermanyGrünenthal GmbHTel: +49 (0) 241 569 1111service@grunenthal.com The NetherlandsMerck Sharp & Dohme BVTel .: 0800 9999000 (+31 23 5153153)medicalinfo.nl@merck.com
EestiMerck Sharp & Dohme OÜTel: + 372 6144 200msdeesti@merck.com NorwayMSD (Norway) ASTel: +47 32 20 73 00msdnorge@msd.no
EladMSD Α.Φ.Β.Ε.Ε.:Ηλ: + 30 210 98 97 300dpoc_greece@merck.com AustriaMerck Sharp & Dohme Ges.mbHTel: +43 (0) 1 26 044msd-medizin@merck.com
SpainMerck Sharp & Dohme de España, SATel: +34 91 321 06 00msd_info@merck.com PolandMSD Polska Sp. z ooTel .: +48 22 549 51 00msdpolska@merck.com
FranceMSD FranceTel: + 33- (0) 1 80 46 40 40 PortugalMerck Sharp & Dohme, LdaTel: + 351 21 446 57 00inform_pt@merck.com
CroatiaMerck Sharp & Dohme dooTel: + 385 1 6611 333croatia_info@merck.com RomaniaMerck Sharp & Dohme Romania SRLTel: + 40 21 529 29 00msdromania@merck.com
IrelandMerck Sharp and Dohme Ireland ( Human Health) LimitedTel: +353 (0) 1 2998700medinfo_ireland@merck.com SloveniaMerck Sharp & Dohme, an innovative freelance dooTel: + 386 1 5204201msd_slovenia@merck.com
IcelandVistor hf.Phone: +354 535 7000 Slovak RepublicMerck Sharp & Dohme, sroTel: +421 2 58282010dpoc_czechslovak@merck.com
ItalyMSD Italia SrlTel: +39 06 361911medicalinformation.it@merck.com Finland / FinlandMSD Finland OyPuh / Tel: +358 (0) 9 804650info@msd.fi
ΚύπροςMerck Sharp & Dohme Cyprus Limited:Ηλ: 800 00 673 (+357 22866700)cyprus _ info @ merck com
LatviaSIA Merck Sharp & Dohme LatvijaTel: + 371 67 364224msd_lv@merck.com United KingdomMerck Sharp & Dohme LimitedTel: + 44 (0) 1992 467272medicalinformationuk@merck.com

Muhammad Nadeem

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