Package leaflet: Information for the patient

Sugammadex AptaPharma, 100 mg/mL, solution for injection
Sugammadexum
Please read this leaflet carefully before the medicine is administered, as it contains
important information for you.

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

Table of contents

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

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

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

What is Sugammadex AptaPharma used for?
During certain types of surgery, the patient's muscles must be completely relaxed. This enables the surgeon to perform the procedure more easily. For this purpose, muscle-relaxing drugs are administered during general anaesthesia. These are known as muscle relaxants and include rocuronium bromide and vecuronium bromide.
Since these drugs also relax the respiratory muscles, assisted breathing (mechanical ventilation) is required during and after surgery until the patient's spontaneous breathing returns.
Sugammadex AptaPharma is used to accelerate the recovery of 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 given to achieve moderate to profound muscle relaxation.

2. Important information before administration of Sugammadex AptaPharma

When not to administer Sugammadex AptaPharma

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

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

if the patient currently has or has previously had kidney disease. This is important because Sugammadex AptaPharma 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.

Children and adolescents
This medicine is not recommended for use in infants under 2 years of age.
Sugammadex AptaPharma 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 AptaPharma may affect the action of other medicines, or other medicines may affect the action of Sugammadex AptaPharma.
Some medicines reduce the effectiveness of Sugammadex AptaPharma
→ 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 AptaPharma may affect the effectiveness of hormonal contraceptives

Sugammadex AptaPharma may reduce the effectiveness of hormonal contraceptives, including oral contraceptives ("the pill"), 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 AptaPharma is approximately equivalent to missing one oral contraceptive tablet. → If taking "the pill" on the same day that Sugammadex AptaPharma 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 device), an additional non-hormonal method of contraception (e.g. condoms) should be used for the next 7 days, and the recommendations in the package leaflet of the specific contraceptive should be followed.

Effect on blood test results
Generally, Sugammadex AptaPharma 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 that Sugammadex AptaPharma is administered.
Pregnancy and breastfeeding
→ Inform the anaesthesiologist if the patient is pregnant or may be pregnant, or if she is breastfeeding. Sugammadex AptaPharma may still be used in pregnant or breastfeeding patients, but this should be discussed with the doctor.
It is unknown whether sugammadex passes into human 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 AptaPharma for the mother.
Driving and operating machinery
Sugammadex AptaPharma has no known effect on the ability to drive or operate machinery.
Sugammadex AptaPharma contains sodium
This medicine contains up to 9.3 mg of sodium (the main component of table salt) per millilitre. This corresponds to 0.5% of the maximum recommended daily sodium intake in the diet for adults.

3. How is Sugammadex AptaPharma administered

Sugammadex AptaPharma 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 AptaPharma based on:

body weight
the dose of neuromuscular blocking agent used.

The usual dose ranges 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 administered in adults.
How Sugammadex AptaPharma is administered
Sugammadex AptaPharma is administered by an anaesthesiologist as a single intravenous injection through an intravenous line.
If more Sugammadex AptaPharma has been administered than recommended
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex AptaPharma is unlikely. Nevertheless, even if this occurs, no problems are expected to arise.
If you have any further questions about the use of this medicine, please consult your anaesthesiologist or another physician.

4. Possible adverse effects

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

Common adverse effects (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 begin to wake up from deep sleep and may require additional anaesthetic. This may cause movement or coughing towards the end of surgery
Complications during the procedure, such as changes in heart rate, coughing or movement
Decreased arterial blood pressure related to the surgical procedure

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

Shortness of breath due to bronchial muscle constriction (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-like reactions may be life-threatening. Occurrence of allergic reactions has been reported more frequently in healthy, awake volunteers
Return of muscle tension to normal state after surgery

Adverse effects with unknown frequency (frequency cannot be estimated from available data)

Following administration of Sugammadex AptaPharma, severe cases of slowing of the heartbeat, including slowing of the heartbeat up to and including cardiac arrest, are possible

Reporting of adverse effects
If any adverse effects occur, including any adverse effects not listed in this leaflet, inform your doctor or pharmacist. Adverse effects can be reported directly to the Department of Monitoring of 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 effects can also be reported to the responsible entity.
Reporting adverse effects helps to provide more information on the safety of the medicine.

5. How to store Sugammadex AptaPharma

Sugammadex AptaPharma will be stored by medical 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 after "EXP". The expiry date refers to the last day of the specified month.
Store below 30°C. Do not freeze.
Keep the vial in the outer packaging to protect from light.
After first opening and dilution, chemical and physical stability has been demonstrated during use for a period of 48 hours at a temperature of 2°C to 25°C, protected from natural light. From a microbiological point of view, the diluted product should be used immediately. If not used immediately, the user is responsible for the storage conditions and duration, which should not exceed 24 hours at a temperature of 2°C to 8°C, unless dilution was carried out under controlled and validated aseptic conditions.

6. Contents of the pack and other information

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, diluted (for pH adjustment) and/or sodium hydroxide (for pH adjustment).

What Sugammadex AptaPharma looks like and contents of the pack
Sugammadex AptaPharma is a clear injection solution, colourless to slightly yellowish-brown.
It is available in two pack sizes containing either 10 vials of 2 mL or 10 vials of 5 mL of solution for injection.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Apta Medica Internacional d.o.o.
Likozarjeva ulica 6
1000 Ljubljana
Slovenia
Tel.: 00386 51 615 015
e-mail: [email protected]

Manufacturer
LABORATORIOS NORMON S.A.
Ronda de Valdecarrizo 6
28760 Tres Cantos – Madrid
Spain

This medicinal product is authorised in the European Economic Area countries under the following names:
Austria Sugammadex AptaPharma 100 mg/ml Injektionslösung
Bulgaria Сугамадекс АптаФарма 100 mg/ ml инжекционен разтвор
Croatia Sugammadeks AptaPharma 100 mg/ml otopina za injekciju
Czech Republic Sugammadex AptaPharma
Poland Sugammadex AptaPharma
Romania Sugammadex AptaPharma 100 mg/ml soluție injectabilă
Slovakia Sugammadex AptaPharma 100 mg/ml injekčný roztok
Slovenia Sugamadeks AptaPharma 100 mg/ml raztopina za injiciranje
Hungary Sugammadex AptaPharma 100 mg/ml oldatos injekció

Information intended exclusively for healthcare professionals:

For detailed information, please refer to the Summary of Product Characteristics for Sugammadex AptaPharma.