Sugammadex Reig Iofre

Package Leaflet: Information for the User

Sugammadex Reig Jofre, 100 mg/mL, Solution for Injection

Sugammadex

Read the package leaflet carefully before using 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, tell the anesthesiologist or another doctor. See section 4.

Table of Contents of the Leaflet

• 1. What is Sugammadex Reig Jofre and what is it used for
• 2. Important information before using Sugammadex Reig Jofre
• 3. How to use Sugammadex Reig Jofre
• 4. Possible side effects
• 5. How to store Sugammadex Reig Jofre
• 6. Contents of the pack and other information

1. What is Sugammadex Reig Jofre and what is it used for

What is Sugammadex Reig Jofre

This medicine contains the active substance sugammadex. Sugammadex Reig Jofre is considered a selective
muscle relaxant binding agent, as it only acts on certain muscle relaxants
- rocuronium bromide or vecuronium bromide.

What is Sugammadex Reig Jofre used for

In case of certain 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 medicines 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 Reig Jofre 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 medicine can be used in adults when rocuronium bromide or vecuronium bromide has been administered, as well as in children and adolescents (from 2 to 17 years old) when rocuronium bromide has been administered for moderate muscle relaxation.

2. Important information before using Sugammadex Reig Jofre

When not to use Sugammadex Reig Jofre

Warnings and precautions

Before starting treatment with Sugammadex Reig Jofre, discuss it with the anesthesiologist:

Children and adolescents

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

Sugammadex Reig Jofre 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 Reig Jofre may affect the action of other medicines, or other medicines may affect the action of Sugammadex Reig Jofre.

Some medicines reduce the effectiveness of Sugammadex Reig Jofre

It is especially important to inform the anesthesiologist if the patient has recently taken the following medicines:

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

Sugammadex Reig Jofre may affect the effectiveness of hormonal contraceptives

Sugammadex Reig Jofre 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 Reig Jofre is roughly equivalent to missing one contraceptive pill.
If the "pill" is taken on the same day that Sugammadex Reig Jofre is administered, follow the instructions for missing a pill in the hormonal contraceptive leaflet.
If otherhormonal contraceptives are used (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 in the contraceptive leaflet.

Effect on blood test results

Usually, Sugammadex Reig Jofre does not affect laboratory test results. However, it may affect the results of blood tests for a hormone called progesterone. Consult a doctor if the progesterone level in the blood needs to be checked on the same day that Sugammadex Reig Jofre is administered.

Pregnancy and breastfeeding

If the patient is pregnant or breastfeeding, thinks she may be pregnant, or plans to have a child, she should consult an anesthesiologist before using this medicine.
The patient can still be given Sugammadex Reig Jofre, 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 baby and the benefits of treatment with Sugammadex Reig Jofre for the mother.

Driving and using machines

Sugammadex Reig Jofre has no known effect on the ability to drive and use machines.

Sugammadex Reig Jofre contains sodium

The medicine contains up to 9.7 mg of sodium (the main component of common salt) per milliliter. This corresponds to 0.5% of the maximum recommended daily intake of sodium in the diet for adults.

3. How to use Sugammadex Reig Jofre

Sugammadex Reig Jofre 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 Reig Jofre based on:

• the patient's body weight,
• the dose of the muscle relaxant used. The usual dose is from 2 mg/kg body weight to 4 mg/kg body weight in adults and children and adolescents from 2 to 17 years old. If rapid recovery of muscle tension is necessary, a dose of 16 mg/kg body weight can be used in adults.

How Sugammadex Reig Jofre is administered

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

Overdose of Sugammadex Reig Jofre

Since the anesthesiologist closely monitors the patient's condition, it is unlikely that an overdose of Sugammadex Reig Jofre will occur. Nevertheless, in the event of such an incident, 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.

Frequent 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 therefore need more anesthetic. This may result in 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 associated with 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 reactions similar to allergic reactions can be life-threatening. Allergic reactions have been reported more frequently in healthy, conscious volunteers;
• Return of muscle relaxation after surgery.

Unknown frequency

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

Reporting side effects

If side effects occur, including any side effects not listed in the leaflet, tell the doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Adverse Reaction Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products:
Aleje Jerozolimskie 181C, 02-222 Warsaw, tel.: +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 Reig Jofre

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:
“EXP”. The expiry date refers to the last day of the month.
Do not freeze.
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.
Do not use this medicine if visible particles are observed.
Medicines should 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 Reig Jofre contains

• The active substance is sugammadex. 1 mL of the 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 (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

What Sugammadex Reig Jofre looks like and contents of the pack

Sugammadex Reig Jofre is a clear solution for injection, colorless to slightly yellow.
It is available in four different pack sizes containing 1 vial or 10 vials of 2 mL or 1 vial or 10 vials of 5 mL solution for injection, in a cardboard box.
Not all pack sizes may be marketed.

Marketing authorization holder

Reig Jofre Sp. z o.o.
ul. Ostródzka 74N
03-289 Warsaw
tel.: +48 22 487 88 49
e-mail: biuro@reigjofre.com

Manufacturer

Laboratorio Reig Jofre, S.A.
Gran Capitan 10
08970 Sant Joan Despí (Barcelona)
Spain

This medicine is authorized in the Member States of the European Economic Area under the following names:

Denmark:
Sugammadex Bioglan
Finland:
Sugammadex Bioglan 100 mg/ml injektioneste, liuos
France:
SUGAMMADEX REIG JOFRE 100 mg/mL, solution injectable
Norway:
Sugammadex Bioglan
Spain:
Sugammadex Sala 100 mg/ml solución inyectable EFG
Sweden:
Sugammadex Bioglan 100 mg/ml injektionsvätska, lösning
Portugal:
Sugamadex Reig Jofre 100 mg/ml solução injetável
Poland:
Sugammadex Reig Jofre

Date of last revision of the leaflet:

Detailed information on this medicine is available on the website of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products
https://rejestrymedyczne.ezdrowie.gov.pl/rpl/search/public
--------------------------------------------------------------------------------------------------------------------
Information intended for healthcare professionals only:
To obtain detailed information, refer to the Summary of Product Characteristics of Sugammadex Reig Jofre.