Package leaflet: Information for the user

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

Keep this leaflet, as you may need to read it again.
If you have any further questions, please consult your anaesthesiologist or another doctor.
If you experience any adverse reactions, including any not listed in this leaflet, please inform your anaesthesiologist or another doctor. See section 4.

Contents of the leaflet

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

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

What is Sugammadex Orion
Sugammadex Orion contains the active substance sugammadex. Sugammadex Orion is considered a
selective relaxant binding agent, because it acts only on specific muscle relaxants –
rocuronium bromide or vecuronium bromide.
Why is Sugammadex Orion used
During certain types of surgery, the patient's muscles must be completely relaxed. This allows the surgeon to perform the procedure more easily. For this purpose, muscle relaxants are administered during general anaesthesia. These are known as
neuromuscular blocking agents, 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 Orion is used to accelerate the recovery of normal muscle function after surgery, enabling earlier restoration of spontaneous breathing. 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 be used in newborns, infants, young children, children and adolescents (from birth up to 17 years of age) when rocuronium bromide has been given.

2. Important information before administration of Sugammadex Orion

When not to administer Sugammadex Orion

if the patient is allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6). In such case, inform the anaesthesiologist.

Warnings and precautions
Before administration of Sugammadex Orion, discuss the following with the anaesthesiologist:

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

Sugammadex Orion and other medicines
Inform the anaesthesiologist about all medicines the patient is currently taking, has recently taken, or plans to take.
Sugammadex Orion may affect the action of other medicines, or other medicines may affect the action of Sugammadex Orion.
Some medicines reduce the effectiveness of Sugammadex Orion.
It is especially important to inform the anaesthesiologist if the following medicines have been taken recently:

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

Sugammadex Orion may affect the effectiveness of hormonal contraceptives

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

Effect on blood test results
Generally, Sugammadex Orion does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Consult the physician if progesterone blood levels need to be measured on the same day Sugammadex Orion is administered.

Pregnancy and breastfeeding
Inform the anaesthesiologist if the patient is pregnant, may be pregnant, or is breastfeeding.
Sugammadex Orion may still be used in pregnant patients, but this should first be discussed with the physician. It is unknown whether sugammadex passes into breast milk. The anaesthesiologist will help the patient decide whether to discontinue breastfeeding or to withhold treatment with sugammadex, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Sugammadex Orion for the mother.

Driving and operating machinery
The effect of Sugammadex Orion on the ability to drive and operate machinery is unknown.

Sugammadex Orion contains sodium
The medicine contains up to 9.5 mg of sodium (the main component of table salt) in each ml of injection solution. This corresponds to 0.5% of the maximum recommended daily dietary sodium intake for adults.

3. How Sugammadex Orion is administered

Sugammadex Orion 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 Orion based on:

the patient's body weight
the dose of neuromuscular blocking agent used.

The usual dose ranges from 2 mg/kg to 4 mg/kg body weight in patients of all ages. If rapid reversal of neuromuscular blockade is required, a dose of 16 mg/kg body weight may be administered in adults.
How Sugammadex Orion is administered
Sugammadex Orion is administered by an anaesthesiologist as a single intravenous injection through an intravenous line.
If more Sugammadex Orion has been administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex Orion is unlikely. Nevertheless, even if this occurs, no problems are expected to arise.
If you have any further questions regarding the use of this medicine, please consult your anaesthesiologist or another physician.

4. Possible adverse reactions

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

Common (may affect up to 1 in 10 people)

Cough
Breathing difficulties, including coughing or movement, such as during awakening or when taking a breath
Light anaesthesia – the patient may start to wake up from deep sleep and therefore may require additional anaesthetic medication. 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 (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, redness of the skin, 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-type reactions may be life-threatening. Allergic reactions have been reported more frequently in healthy, awake volunteers.
Return of muscle weakness after surgery

Unknown frequency (frequency cannot be estimated from the available data)

Following administration of Sugammadex Orion, 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 anaesthesiologist or another doctor immediately. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions at 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 authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Sugammadex Orion

The medicine will be stored by healthcare personnel.
Keep the medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton and label after
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
Do not freeze.
Store the vials in the outer packaging to protect from light.
After first opening and dilution, store at a temperature from 2°C to 8°C and use within 24 hours.
Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the package and other information

What the medicine Sugammadex Orion contains

The active substance is sugammadex. 1 ml of injection solution contains sugammadex sodium equivalent to 100 mg of sugammadex. Each 2 ml vial contains sugammadex sodium equivalent to 200 mg of sugammadex.
Other components are: hydrochloric acid (for pH adjustment), sodium hydroxide (for pH adjustment), and water for injections.

What the medicine Sugammadex Orion looks like and contents of the pack
Sugammadex Orion is a clear, colourless to slightly yellow injection solution, practically free from particulate matter.
Pack sizes:
10 vials of 2 ml.
Marketing Authorisation Holder
Orion Corporation
Orionintie 1
FI-02200 Espoo
Finland
Manufacturer
Orion Corporation Orion Pharma
Orionintie 1
FI-02200 Espoo
Finland
Orion Corporation Orion Pharma
Joensuunkatu 7
FI-24100 Salo
Finland
For more detailed information about this medicine, please contact the local representative of the Marketing Authorisation Holder:
Orion Pharma Poland Sp. z o.o.
[email protected]

Information intended exclusively for healthcare professionals:

For detailed information, please refer to the Product Information Leaflet of
Sugammadex Orion.