Sugammadex delfarma

Package leaflet: Information for the user

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

• Keep this leaflet, as you may need to read it again.
• If you have any further questions, ask your anaesthetist or another doctor.
• If you experience any adverse reactions, including any not listed in this leaflet, tell your anaesthetist or another doctor immediately. See section 4.

Contents of the leaflet

1. What Sugammadex Delfarma is and what it is used for
2. What you need to know before being given Sugammadex Delfarma
3. How Sugammadex Delfarma is administered
4. Possible side effects
5. How to store Sugammadex Delfarma
6. Contents of the pack and other information

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

What Sugammadex Delfarma is
Sugammadex Delfarma contains the active substance sugammadex. Sugammadex Delfarma is considered a selective relaxant binding agent, because it acts only on specific muscle relaxants – rocuronium bromide or vecuronium bromide.

Why Sugammadex Delfarma is used
During certain types of surgery, the patient's muscles must be completely relaxed to allow the surgeon easier access and better operating conditions. For this purpose, muscle-relaxing medicines are administered during general anaesthesia. These are known as neuromuscular blocking agents, and include rocuronium bromide and vecuronium bromide. Since these medicines also paralyse the respiratory muscles, assisted ventilation (mechanical ventilation) is required during and after surgery until the patient's spontaneous breathing returns.

Sugammadex Delfarma 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 who have received rocuronium bromide or vecuronium bromide.
It may also be used in newborns, infants, young children, children, and adolescents (from birth up to 17 years of age) who have received rocuronium bromide.

2. Important information before administration of Sugammadex Delfarma

When not to administer Sugammadex Delfarma

• 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 Delfarma, discuss the following with the anaesthesiologist:

• if the patient has or has had kidney disease in the past. This is important because Sugammadex Delfarma is eliminated from the body via the kidneys.
• if the patient currently has or has previously had liver disease.
• 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 Delfarma 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 Delfarma may affect the action of other medicines, or other medicines may affect the action of Sugammadex Delfarma.
Some medicines reduce the effectiveness of Sugammadex Delfarma
It is particularly 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 Delfarma may affect the effectiveness of hormonal
contraceptives
Sugammadex Delfarma may reduce the effectiveness of hormonal contraceptives, including oral contraceptive pills, vaginal contraceptive systems, implants, or transdermal contraceptive systems releasing progestogen (hormonal intrauterine device), because it reduces the amount of hormone delivered. The amount of progestogen lost due to administration of Sugammadex Delfarma is approximately equivalent to missing one dose of oral contraceptive.

• If taking an oral contraceptive pill on the same day Sugammadex Delfarma is administered, follow the instructions for missed pill provided in the package leaflet of the hormonal contraceptive.
• If using other hormonal contraceptives (such as a vaginal ring, implant, or hormonal intrauterine device), use an additional non-hormonal contraceptive method (e.g. condoms) for the next 7 days and follow the recommendations provided in the leaflet of the respective contraceptive product.

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

Pregnancy and breastfeeding
Inform the anaesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding.
Sugammadex Delfarma may still be used in pregnant patients, but this should be discussed with the doctor.
It is unknown whether sugammadex passes into breast 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 Delfarma for the mother.

Driving and operating machinery
Sugammadex Delfarma has no known effect on the ability to drive or operate machinery.

Sugammadex Delfarma contains sodium
The medicine contains up to 9.7 mg of sodium (the main component of table salt) per millilitre of injection solution.

Dose less than or equal to 2.4 mL
The medicine contains less than 1 mmol (23 mg) of sodium per 2.4 mL dose (or lower), meaning the medicine is considered "sodium-free".

Dose greater than 2.4 mL
The medicine contains 23 mg (or more) of sodium (the main component of table salt) in a 2.4 mL (or higher) dose. This corresponds to 1.15% (or more) of the maximum recommended daily dietary sodium intake for adults.

Inform the anaesthesiologist if the patient is on a sodium-controlled diet.

3. How the medicine Sugammadex Delfarma is administered

Sugammadex Delfarma 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 Delfarma based on:

• body weight
• the dose of neuromuscular blocking agent used.

The usual dose is 2–4 mg/kg body weight in patients of all ages. If rapid reversal of neuromuscular blockade is urgently required, a dose of 16 mg/kg body weight may be administered in adults.
How Sugammadex Delfarma is administered
Sugammadex Delfarma is administered by the anaesthesiologist as a single intravenous injection through an intravenous line.
If more Sugammadex Delfarma is administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex Delfarma 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 doctor.

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 adverse reactions (may occur in up to 1 in 10 people)

• Coughing
• Breathing difficulties, including coughing or movement, such as during emergence from anaesthesia or during inspiration
• Light anaesthesia – the patient may begin to wake up from deep sleep and 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
• Reduced blood pressure associated with the surgical procedure

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

• Shortness of breath due to bronchospasm (airway muscle spasm) 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-type 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 the available data)

• Following administration of Sugammadex Delfarma, severe cases of bradycardia (slow heart rate) are possible, including slowing of the heart rate up to and including cardiac arrest.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform the anaesthesiologist or another physician. Adverse reactions can be reported directly to the Department for 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 provide more information on the safety of the medicine.

5. How to store Sugammadex Delfarma

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 carton and label following:
"Expiry date (EXP)". The expiry date refers to the last day of the stated month.
This medicine does not require any special temperature storage conditions.
Store vials in the outer packaging to protect from light.
After first opening and dilution, store between 2°C and 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. This will help protect the environment.

6. Contents of the pack and other information

What Sugammadex Delfarma 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.

• The other ingredients are: water for injections, hydrochloric acid (for pH adjustment) and (or) sodium hydroxide (for pH adjustment).

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

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Delfarma Sp. z o.o.
ul. św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
tel. 42 61 32 800
fax 42 61 32 802
e-mail: [email protected]

Manufacturer
Synthon Hispania S.L.
Calle de Castello 1, Poligono Las Salinas
Sant Boi de Llobregat
08830 Barcelona
Spain
Synthon B.V.
Microweg 22
6545 CM Nijmegen
The Netherlands
Delfarma sp. z o.o.
Dostawcza 17
93-231 Łódź
Poland

Information intended exclusively for healthcare professionals:

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