Sugammadex Ranbaxi

Leaflet attached to the packaging: patient information

Sugammadex Ranbaxy, 100 mg/mL, solution for injection

sugammadex

Read the 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 a doctor or anesthesiologist.
• If the patient experiences any side effects, including any side effects not listed in this leaflet, tell the doctor or anesthesiologist. See section 4.

Table of contents of the leaflet

• 1. What is Sugammadex Ranbaxy and what is it used for
• 2. Important information before using Sugammadex Ranbaxy
• 3. How to use Sugammadex Ranbaxy
• 4. Possible side effects
• 5. How to store Sugammadex Ranbaxy
• 6. Package contents and other information

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

What is Sugammadex Ranbaxy

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

What is Sugammadex Ranbaxy 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 medications 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 Ranbaxy is used to accelerate the return of muscles to their normal state after surgery, allowing the patient to breathe on their own sooner. 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 (aged 2 to 17) when rocuronium bromide has been administered for moderate muscle relaxation.

2. Important information before using Sugammadex Ranbaxy

When not to use Sugammadex Ranbaxy

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

Warnings and precautions

Before administering Sugammadex Ranbaxy, discuss it with the anesthesiologist

• if the patient has or has had kidney disease. This is important because Sugammadex Ranbaxy is eliminated from the body through the kidneys;
• if the patient has or has had liver disease;
• if the patient has fluid retention (edema);
• if the patient has conditions that increase the risk of bleeding (blood clotting disorders) or is taking anticoagulant medications.

Children and adolescents

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

Sugammadex Ranbaxy 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 Ranbaxy may affect the action of other medicines or other medicines may affect the action of Sugammadex Ranbaxy.

Some medicines reduce the effectiveness of Sugammadex Ranbaxy

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 Ranbaxy may affect the effectiveness of hormonal contraceptives

Sugammadex Ranbaxy may reduce the effectiveness of hormonal contraceptives, including "pills", vaginal rings, implants, or intrauterine systems that release progestogen (hormonal intrauterine device), as it reduces the amount of hormone delivered. The amount of progestogen lost due to the use of Sugammadex Ranbaxy is roughly equivalent to missing one contraceptive pill.

• In the case of taking "pills" on the same day that Sugammadex Ranbaxy is administered, follow the instructions for missing a "pill" contained in the hormonal contraceptive leaflet,
• In the case of using other hormonal contraceptives (such as vaginal rings, implants, or hormonal intrauterine devices), use an additional non-hormonal contraceptive method (e.g., condoms) for the next 7 days and follow the recommendations contained in the leaflet for the specific product.

Effect on blood test results

Usually, Sugammadex Ranbaxy 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 is to be tested on the same day that Sugammadex Ranbaxy is administered.

Pregnancy and breastfeeding

Inform the anesthesiologist about existing pregnancy, suspected pregnancy, or breastfeeding. The patient can still be given Sugammadex Ranbaxy, but this should be discussed with the doctor. It is not known whether sugammadex passes into breast milk. The anesthesiologist will help decide whether to stop breastfeeding or discontinue sugammadex therapy, considering the benefits of breastfeeding for the child and the benefits of Sugammadex Ranbaxy for the mother.

Driving and using machines

The effect of Sugammadex Ranbaxy on the ability to drive and use machines is not known.

Sugammadex Ranbaxy contains sodium

This medicine contains 9.7 mg of sodium (a major component of common salt/table salt) per milliliter. Dose less than or equal to 2.4 mL: The dose contains less than 1 mmol of sodium (23 mg) per mL, i.e., the medicine is considered "sodium-free". Dose above 2.4 mL: The dose contains 1 mmol (or more) of sodium (23 mg) per mL. This corresponds to 1.15% (or more) of the maximum recommended daily intake of sodium in the diet for adults. Patients on a controlled sodium diet should inform the anesthesiologist.

3. How to use Sugammadex Ranbaxy

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

Dose

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

• body weight,
• the dose of the muscle relaxant used.

Typically, the dose used is from 2 mg/kg body weight to 4 mg/kg body weight for adults and for children and adolescents aged 2-17. If rapid recovery of muscle tension is necessary after relaxation, a dose of 16 mg/kg body weight can be used in adults.

How Sugammadex Ranbaxy is administered

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

Using more than the recommended dose of Sugammadex Ranbaxy

Since the anesthesiologist closely monitors the patient's condition, it is unlikely that Sugammadex Ranbaxy will be overdosed. 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 the 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(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(may occur in up to 1 in 100 people)

• Shortness of breath due to bronchospasm in patients with a history of respiratory disease
• Allergic reactions (hypersensitivity to the medicine) - such as rash, skin redness, tongue and/or throat swelling, shortness of breath, changes in blood pressure or heart rhythm, sometimes resulting in severe hypotension. Severe allergic reactions or anaphylaxis-like reactions can be life-threatening. The occurrence of allergic reactions has been reported more frequently in healthy, conscious volunteers.
• Return of muscle tension after surgery

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

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

Reporting side effects

If you experience any side effects, including any side effects not listed in this leaflet, tell your doctor, pharmacist, or nurse. Side effects can be reported directly to the Department of Drug Safety Monitoring of the Office for Registration of Medicinal Products, Medical Devices, and Biocidal Products: Al. Jerozolimskie 181C, 02-222 Warsaw, tel.: 22 49-21-301, fax: 22 49-21-309, website: https://smz.ezdrowie.gov.pl. Side effects can also be reported to the marketing authorization holder. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Sugammadex Ranbaxy

The medicine will be stored by healthcare professionals. The medicine should be stored 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. There are no special storage instructions for the temperature. Store the vial 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. Package contents and other information

What Sugammadex Ranbaxy contains

• The active substance is sugammadex. 1 mL of the solution for injection contains 100 mg of sugammadex as sugammadex sodium. Each 2 mL vial contains 200 mg of sugammadex as sugammadex sodium. Each 5 mL vial contains 500 mg of sugammadex as sugammadex sodium.
• The other ingredients are: water for injections, hydrochloric acid (to adjust pH) and/or sodium hydroxide (to adjust pH).

What Sugammadex Ranbaxy looks like and what the pack contains

Sugammadex Ranbaxy is a clear solution for injection, colorless to slightly yellow-brown, 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 of the solution for injection. Not all pack sizes may be marketed.

Marketing authorization holder

Ranbaxy (Poland) Sp. z o.o. ul. Idzikowskiego 16, 00-710 Warsaw

Manufacturer/Importer

Synthon Hispania S.L. Calle De Castello 1, 08830 Sant Boi De Llobregat, Barcelona, Spain Synthon B.V. Microweg 22, 6545 CM Nijmegen, Gelderland, Netherlands Date of last revision of the leaflet:15.06.2023