Patient Information Leaflet

Sugammadex MSN, 100 mg/mL, solution for injection
Sugammadexum
Please read all of this leaflet carefully before the medicine is administered, as it contains
important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please ask your anaesthetist or another doctor.
If you experience any side effects, including any not listed in this leaflet, tell your anaesthetist or another doctor. See section 4.

Leaflet Contents:

What Sugammadex MSN is and what it is used for
Important information before receiving Sugammadex MSN
How Sugammadex MSN is given
Possible side effects
How to store Sugammadex MSN
Contents of the pack and other information

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

What Sugammadex MSN is
Sugammadex MSN contains the active substance sugammadex. Sugammadex is considered a
selective relaxant binding agent because it acts only on specific muscle relaxants – rocuronium bromide or vecuronium bromide.
What Sugammadex MSN is used for
During certain types of surgery, the patient's muscles must be completely relaxed. This enables the surgeon to perform the procedure more easily. For this purpose, muscle-relaxing drugs are administered during general anaesthesia. These are known as muscle relaxants and include rocuronium bromide and vecuronium bromide. Since these drugs also relax the respiratory muscles, assisted ventilation (mechanical ventilation) is required during and after surgery until the patient's spontaneous breathing returns.
Sugammadex MSN is used to accelerate the recovery of normal muscle function after surgery, enabling the patient to breathe independently again sooner. It works by binding to rocuronium bromide or vecuronium bromide in the body. The medicine can be used in adults when rocuronium bromide or vecuronium bromide has been administered. It can also be used in children and adolescents (aged 2 to 17 years) when rocuronium bromide has been given to achieve moderate neuromuscular block.

2. Important information before administration of Sugammadex MSN

When not to use Sugammadex MSN

if the patient is allergic to sugammadex or to any of the other ingredients of this medicine (listed in section 6).

→ In such case, inform the anaesthesiologist.
Warnings and precautions
Before starting administration of Sugammadex MSN, discuss the following with the anaesthesiologist:

if the patient has or has had kidney disease in the past. This is important because sugammadex is eliminated from the body through the kidneys.
if the patient currently has or has had liver disease in the past.
if the patient has fluid retention in the body (edema).
if the patient has diseases known to increase the risk of bleeding (coagulation disorders) or is taking anticoagulant medicines.

Children and adolescents
This medicine is not recommended for use in children under 2 years of age.
Sugammadex MSN and other medicines
→ Inform the anaesthesiologist about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Sugammadex MSN may affect the action of other medicines or other medicines may affect the action of Sugammadex MSN.
Some medicines reduce the effectiveness of Sugammadex MSN
→ It is especially important to inform the anaesthesiologist if the patient has recently taken any of the following medicines:

toremifene (used in the treatment of breast cancer).
fusidic acid (an antibiotic).

Sugammadex MSN may affect the effectiveness of hormonal contraceptives

Sugammadex MSN may reduce the effectiveness of hormonal contraceptives, including oral contraceptives ("the pill"), vaginal contraceptive systems, implants, or transdermal therapeutic systems releasing progestogen (hormone-releasing intrauterine device), because it reduces the amount of hormone delivered. The amount of progestogen lost due to administration of Sugammadex MSN is approximately equivalent to missing one dose of oral contraceptive. → If taking an oral contraceptive pill on the same day Sugammadex MSN is administered, follow the instructions for missed dose provided in the package leaflet of the hormonal contraceptive. → If using other hormonal contraceptives (such as a vaginal contraceptive system, implant, or hormone-releasing intrauterine device), an additional non-hormonal method of contraception (e.g. condoms) should be used for the next 7 days, and follow the recommendations provided in the leaflet of the specific contraceptive product.

Effect on blood test results
Generally, Sugammadex MSN does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Please consult the doctor if progesterone blood levels need to be measured on the same day Sugammadex MSN is administered.
Pregnancy and breastfeeding
→ Inform the anaesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding.
The patient may still be given Sugammadex MSN, but this should be discussed with the doctor first.
It is not known whether sugammadex passes into human milk. The anaesthesiologist will help the patient decide whether to discontinue breastfeeding or to refrain from treatment with sugammadex, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Sugammadex MSN for the mother.
Driving and operating machinery
Sugammadex MSN has no known influence on the ability to drive and operate machinery.
Sugammadex MSN contains sodium
This medicine contains up to 9.4 mg of sodium (the main component of table salt) per millilitre. This corresponds to 0.5% of the maximum recommended daily dietary intake of sodium for adults.

3. How to administer Sugammadex MSN

Sugammadex MSN will be administered to the patient by an anaesthesiologist or under the supervision of an anaesthesiologist.
Dosage
The anaesthesiologist will adjust the dose of Sugammadex MSN based on:

the patient's body weight,
the intensity of the muscle relaxant effect in the patient.

The usual dose of sugammadex is 2 to 4 mg/kg body weight in adults and children and adolescents aged 2–17 years. If rapid reversal of neuromuscular blockade is urgently required, a dose of 16 mg/kg body weight may be used in adults.
How Sugammadex MSN is administered
Sugammadex MSN will be administered by the anaesthesiologist as a single intravenous injection via an intravenous line (intravenous administration).
If more Sugammadex MSN has been administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex MSN is unlikely. Nevertheless, if such an event occurs, no problems are expected to arise.
If you have any further questions regarding the use of this medicine, please consult the anaesthesiologist or another physician.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone will experience them.
If these adverse reactions occur during anaesthesia, they will be noticed and treated by the anaesthetist.

Common adverse reactions (may affect up to 1 in 10 people)

Coughing.
Breathing difficulties, including coughing or movement, such as during emergence or at the start of inspiration.
Light anaesthesia – the patient may begin to wake up from deep sleep and may require additional anaesthetic. This may result in movement or coughing towards the end of surgery.
Complications during the procedure, such as changes in heart rate, coughing or movement.
Decreased blood pressure related to the surgical procedure.

Uncommon adverse reactions (may affect up to 1 in 100 people)

Shortness of breath due to bronchial muscle spasm (bronchospasm) occurring in patients with a history of lung disease.
Allergic reactions (hypersensitivity to the medicine) – such as rash, skin redness, swelling of the tongue and/or throat, shortness of breath, changes in blood pressure or heart rhythm, sometimes leading to severe drop in blood pressure. Severe allergic or allergic-like reactions may be life-threatening. Allergic reactions have been reported more frequently in healthy, awake volunteers.
Return of muscle relaxation after surgery.

Frequency not known (frequency cannot be estimated from available data)

After administration of Sugammadex MSN, severe cases of bradycardia, including bradycardia progressing to cardiac arrest, are possible.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the anaesthetist or another doctor immediately. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorisation holder.
Reporting adverse reactions helps to provide more information on the safety of the medicine.

5. How to store Sugammadex MSN

The medicine will be stored by healthcare professionals.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the cardboard box and on the label of the vial after: EXP. The expiry date refers to the last day of the stated month.
There are no special storage temperature requirements for this medicine.
Store the vial in the outer packaging to protect it from light.
After first opening and dilution, store at 2°C - 8°C and use within 24 hours.

6. Contents of the package and other information

What Sugammadex MSN contains

The active substance is sugammadex. 1 mL of the injection solution contains sodium sugammadex equivalent to 100 mg of sugammadex. Each 2 mL vial contains sodium sugammadex equivalent to 200 mg of sugammadex. Each 5 mL vial contains sodium sugammadex equivalent to 500 mg of sugammadex.
Other ingredients are: water for injections, hydrochloric acid, concentrated 0.36% (for pH adjustment) and (or) sodium hydroxide 0.4% (for pH adjustment).

What Sugammadex MSN looks like and contents of the pack
Sugammadex MSN is a clear, colourless to slightly yellow solution for injection.
It is available in two different pack sizes containing either 10 vials of 2 mL or 10 vials of 5 mL of solution for injection.
Not all pack sizes may be marketed.

Marketing Authorisation Holder:
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta
Tel.: (+48) 699 711 147
{logo of the marketing authorisation holder}

Manufacturer/Importer:
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola, PLA 3000
Malta
MSN Labs Europe Limited
KW20A Corradino Park
Paola, PLA 3000
Malta

This medicinal product is authorised in the European Economic Area member states under the following names:
Germany Sugammadex Vivanta 100 mg/ml Injektionslösung
Spain Sugammadex Vivanta 100 mg/ml solución inyectable EFG
Netherlands Sugammadex Vivanta 100 mg/ml, oplossing voor injectie
Cyprus Sugammadex MSN 100 mg/ml, solution for injection
Ireland Sugammadex 100 mg/mL solution for injection
Portugal Sugammadex Vivanta
France SUGAMMADEX Vivanta 100 mg/mL, solution injectable
Bulgaria Sugammadex MSN 100 mg/ml, solution for injection
Hungary Sugammadex MSN 100 mg/ml oldatos injekció
Croatia Sugamadeks MSN 100 mg/ml otopina za injekciju
Slovenia Sugamadeks MSN 100 mg/ml raztopina za injiciranje
Estonia Sugammadex MSN
Latvia Sugammadex MSN 100 mg/ml šķīdums injekcijām
Lithuania Sugammadex MSN 100 mg/ml injekcinis tirpalas
Poland Sugammadex MSN
Malta Sugammadex MSN 100 mg/ml solution for injection

Information intended exclusively for healthcare professionals:

For detailed information, please refer to the Summary of Product Characteristics for
Sugammadex MSN.