Sugammadex reig jofre

Package leaflet: Information for the user

Sugammadex Reig Jofre, 100 mg/mL, solution for injection
Sugammadexum
Please read all of this leaflet carefully before use, as it contains
important information for the patient.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, please consult your anaesthetist or another doctor.
• If the patient experiences any adverse reactions, including any adverse reactions not listed in this leaflet, inform the anaesthetist or another doctor immediately. See section 4.

Leaflet contents

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
neuromuscular blocking agent binding agent, because it acts only on specific muscle relaxants –
rocuronium bromide or vecuronium bromide.
Why is Sugammadex Reig Jofre 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 regains spontaneous breathing.
Sugammadex Reig Jofre 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, and also in children and adolescents (aged 2 to 17 years) when rocuronium bromide has been used to achieve moderate to profound muscle relaxation.

2. Important information before using Sugammadex Reig Jofre

When not to use Sugammadex Reig Jofre

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

Warnings and precautions
Before starting treatment with Sugammadex Reig Jofre, discuss the following with the anaesthesiologist:

• if the patient currently has or has previously had kidney disease. This is important because Sugammadex Reig Jofre 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 disorders known to increase the risk of bleeding (blood clotting disorders) or is taking anticoagulant medicines.

Children and adolescents
This medicine is not recommended for use in infants under 2 years of age.

Sugammadex Reig Jofre 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 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 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 Reig Jofre may affect the effectiveness of hormonal
contraceptives
Sugammadex Reig Jofre may reduce the effectiveness of hormonal contraceptives, including oral contraceptives ("the pill"), vaginal ring, implant, or transdermal delivery system releasing progestogen (hormonal intrauterine system), because it reduces the amount of hormone delivered. The amount of progestogen lost due to administration of Sugammadex Reig Jofre is approximately equivalent to missing one oral contraceptive tablet.
If taking an oral contraceptive ("the pill") on the same day that Sugammadex Reig Jofre 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 ring, implant, or hormonal intrauterine system), use an additional non-hormonal method of contraception (e.g. condoms) for the next 7 days and follow the recommendations provided in the contraceptive's package leaflet.

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

Pregnancy and breastfeeding
If the patient is pregnant or breastfeeding, suspects she may be pregnant, or is planning to have a child, she should consult the anaesthesiologist before using this medicine.
Sugammadex Reig Jofre may still be used in pregnant patients, but this should be discussed with the doctor.
It is not known whether sugammadex passes into human milk. The anaesthesiologist will help the patient decide whether to stop 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 Reig Jofre for the mother.

Driving and operating machinery
Sugammadex Reig Jofre has no known influence on the ability to drive or operate machinery.

Sugammadex Reig Jofre contains sodium
This medicine contains up to 9.7 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 use Sugammadex Reig Jofre

Sugammadex Reig Jofre 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 Reig Jofre based on:

• the patient's body weight,
• the dose of neuromuscular blocking agent used. The usual dose is from 2 mg/kg to 4 mg/kg body weight in adults and children and adolescents aged 2–17 years. If rapid reversal of neuromuscular blockade is required, a dose of 16 mg/kg body weight may be used in adults.

How Sugammadex Reig Jofre is administered
Sugammadex Reig Jofre is administered by an anaesthesiologist as a single intravenous injection through an intravenous line.
Use of a higher than recommended dose of Sugammadex Reig Jofre
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex Reig Jofre is unlikely. However, even if this occurs, no problems are expected to arise.
If you have any further doubts 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 not everyone will experience them.
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 awakening or taking a breath.
• Light anaesthesia – the patient may start to wake up from deep sleep and therefore 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.
• 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 bronchial muscle spasms (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, conscious volunteers.
• Return of muscle weakness after surgery.

Frequency not known

• Following administration of Sugammadex Reig Jofre, severe cases of bradycardia (slow heart rate) as well as slowing of the heart rate up to and including cardiac arrest may occur.

Reporting of adverse reactions
If any adverse reactions occur, including any adverse reactions not listed in this leaflet, inform a doctor, pharmacist, or nurse. 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, phone: +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 to provide more information on the safety of the medicine.

5. How to store Sugammadex Reig Jofre

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 following:
"EXP". The expiry date refers to the last day of the stated month.
Do not freeze.
Store vials in the outer packaging to protect from light.
After first opening and dilution, store at a temperature between 2°C and 8°C and use within 24 hours.
Do not use this medicine if visible particles are observed.
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 the medicinal product Sugammadex Reig Jofre 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 components are: water for injections, hydrochloric acid (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

What the medicinal product Sugammadex Reig Jofre looks like and contents of the pack
Sugammadex Reig Jofre is a clear, colourless to slightly yellow injection solution.
It is available in four different pack sizes containing either 1 vial or 10 vials of 2 mL or 1 vial or 10 vials of 5 mL injection solution, in a cardboard box.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
Reig Jofre Sp. z o.o.
Ostródzka Street 74N
03-289 Warsaw
Tel.: +48 22 487 88 49
E-mail: [email protected]

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

This medicinal product is authorised in the European Economic Area countries 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

Detailed information about this medicinal product 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 exclusively for healthcare professionals:

For detailed information, please refer to the Sugammadex Reig Jofre Product Information.