Sugammadex Delfarma

Leaflet attached to the packaging: information for the user

Sugammadex Delfarma, 100 mg/mL, solution for injection

Sugammadex

Read the leaflet carefully before administering the medicine, as it contains important information for the patient.

• Keep this leaflet, you may need to read it again.
• In case of any doubts, consult an anesthesiologist or another doctor.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, inform the anesthesiologist or another doctor. See section 4.

Table of contents of the leaflet

• 1. What is Sugammadex Delfarma and what is it used for
• 2. Important information before administering Sugammadex Delfarma
• 3. How Sugammadex Delfarma is administered
• 4. Possible side effects
• 5. How to store Sugammadex Delfarma
• 6. Contents of the packaging and other information

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

What is Sugammadex Delfarma

Sugammadex Delfarma contains the active substance sugammadex. Sugammadex Delfarma is considered a selective relaxant binding agentbecause it only acts on certain muscle relaxants - rocuronium bromide or vecuronium bromide.

What is Sugammadex Delfarma used for

In some types of surgery, the patient's muscles must be completely relaxed. This allows the surgeon to perform the operation more easily. To achieve this, muscle relaxants are administered during general anesthesia. These are called muscle relaxantsand include rocuronium bromide and vecuronium bromide. Since these drugs also cause relaxation of the respiratory muscles, assisted breathing (artificial ventilation) is necessary during and after surgery until the patient's own breathing returns.
Sugammadex Delfarma is used to accelerate the recovery of muscles after surgery, so that the patient can breathe on their own as soon as possible. Its action involves binding to rocuronium bromide or vecuronium bromide in the body.
The drug can be used in adults when rocuronium bromide or vecuronium bromide has been administered, as well as in children and adolescents (aged 2 to 17) when rocuronium bromide has been administered for moderate muscle relaxation.

2. Important information before administering Sugammadex Delfarma

When not to administer Sugammadex Delfarma

Warnings and precautions

Before administering Sugammadex Delfarma, discuss it with the anesthesiologist

Children and adolescents

It is not recommended to use this medicine in infants under 2 years of age.

Sugammadex Delfarma and other medicines

Tell the anesthesiologist about all medicines the patient is 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 especially important to inform the anesthesiologist if the patient has taken the following medicines recently:

• toremifene (used to treat 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 the "pill", vaginal ring, implant, or intrauterine system releasing progestogen (hormonal intrauterine device), as it reduces the amount of hormone delivered. The amount of progestogen lost due to the use of Sugammadex Delfarma is roughly equivalent to missing one contraceptive pill.

Effect on blood test results

Normally, Sugammadex Delfarma does not affect laboratory test results. However, it may affect the results of blood tests for a hormone called progesterone. Inform the doctor if the progesterone level in the blood is to be tested on the same day that Sugammadex Delfarma is administered.

Pregnancy and breastfeeding

Inform the anesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding.
Sugammadex Delfarma can still be used in the patient, but this should be discussed with the doctor.
It is not known whether sugammadex passes into breast milk. The anesthesiologist will help the patient decide whether to stop breastfeeding or avoid treatment with sugammadex, considering the benefits of breastfeeding for the child and the benefits of treatment with Sugammadex Delfarma for the mother.

Driving and using machines

Sugammadex Delfarma has no known effect on the ability to drive or use machines.

Sugammadex Delfarma contains sodium

The medicine contains up to 9.7 mg of sodium (the main component of common salt) per milliliter of solution for injection.
Dose less than or equal to 2.4 mL
The medicine contains less than 1 mmol (23 mg) of sodium per dose of 2.4 mL (or less), which means 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 common salt) per dose of 2.4 mL (or more). This corresponds to 1.15% (or more) of the maximum recommended daily intake of sodium in the diet for adults.
Inform the anesthesiologist if the patient is on a low-salt diet.

3. How Sugammadex Delfarma is administered

Sugammadex Delfarma will be administered to the patient by an anesthesiologist or under the supervision of an anesthesiologist.

Dose

The anesthesiologist will adjust the dose of Sugammadex Delfarma based on:

• body weight
• dose of muscle relaxant used.

The usual dose in adults and children and adolescents aged 2 to 17 years is 2 mg/kg to 4 mg/kg of body weight. If rapid recovery of muscle tension is necessary, a dose of 16 mg/kg of body weight can be used in adults.

How Sugammadex Delfarma is administered

Sugammadex Delfarma is administered by an anesthesiologist. It is given as a single injection through an intravenous line.

If more Sugammadex Delfarma is administered than recommended

Since the anesthesiologist closely monitors the patient's condition, it is unlikely that an overdose of Sugammadex Delfarma will occur. Nevertheless, in the event of such an occurrence, no problems should arise.
In case of any further doubts about the use of this medicine, consult an anesthesiologist 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 during anesthesia, they will be noticed and treated by the anesthesiologist.

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

• Cough
• Difficulty breathing, including coughing or moving, such as when waking up or taking a breath
• Mild anesthesia - the patient may start to wake up from deep sleep and need more anesthetic. This can cause movement or coughing at the end of the operation.
• Complications during the procedure, such as changes in heart rate, coughing, or moving
• Decreased blood pressure related to the surgical procedure.

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

• Shortness of breath due to bronchospasm 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 rate, sometimes resulting in severe hypotension. Severe allergic reactions or anaphylaxis can be life-threatening. Allergic reactions have been reported more frequently in healthy, conscious volunteers
• Return of muscle relaxation after surgery.

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

• After administration of Sugammadex Delfarma, severe cases of bradycardia, including bradycardia leading to cardiac arrest, are possible.

Reporting side effects

If any side effects occur, including any side effects not listed in this leaflet, inform the anesthesiologist or another doctor. Side effects can be reported directly to the Department of Pharmacovigilance of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products, Al. Jerozolimskie 181C, 02-222 Warsaw
Phone: +48 22 49 21 301
Fax: +48 22 49 21 309
Website: https://smz.ezdrowie.gov.pl
Side effects can also be reported to the marketing authorization holder.
Reporting side effects will help to gather more information on the safety of the medicine.

5. How to store Sugammadex Delfarma

The medicine will be stored by healthcare professionals.
Store the medicine out of 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 month.
This medicine does not require any special storage precautions.
Store the vials in the outer packaging to protect from light.
After first opening and dilution, store in a refrigerator (2°C - 8°C) and use within 24 hours.

6. Contents of the packaging and other information

What Sugammadex Delfarma contains

• The active substance is sugammadex. 1 mL of solution for injection contains sugammadex sodium equivalent to 100 mg of sugammadex. Each 2 mL vial contains sugammadex sodium equivalent to 200 mg of sugammadex.

Each 5 mL vial contains sugammadex sodium equivalent to 500 mg of sugammadex.

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

What Sugammadex Delfarma looks like and contents of the packaging

Sugammadex Delfarma is a clear solution for injection, colorless to slightly yellow, practically free from particulate matter.
It is available in two different pack sizes containing 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 authorization holder

Delfarma Sp. z o.o.
ul. św. Teresy od Dzieciątka Jezus 111
91-222 Łódź
phone: 42 61 32 800
fax: 42 61 32 802
e-mail: info@delfarma.pl

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
Netherlands
Date of last revision of the leaflet:15.07.2022
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Information intended for healthcare professionals only:

To obtain detailed information, refer to the Summary of Product Characteristics of Sugammadex Delfarma.