Package leaflet: Information for the patient

Sugammadex Ranbaxy, 100 mg/mL, solution for injection
sugammadex
Please read this leaflet carefully before using this medicine because it contains important information for you.

Keep this leaflet. You may need to read it again.
If you have any further questions, please consult your doctor or anaesthesiologist.
If you experience any side effects, including any not listed in this leaflet, please inform your doctor or anaesthesiologist. See section 4.

Leaflet contents

What Sugammadex Ranbaxy is and what it is used for
What you need to know before you are given Sugammadex Ranbaxy
How Sugammadex Ranbaxy is given
Possible side effects
How to store Sugammadex Ranbaxy
Contents of the pack and other information

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

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

Why Sugammadex Ranbaxy is used
During certain types of surgery, a patient's muscles must be completely relaxed. This allows the surgeon to perform the procedure more easily. For this reason, muscle-relaxing medicines are administered during general anaesthesia. These are known as muscle relaxants, and include rocuronium bromide and vecuronium bromide.
Since these medicines also relax the muscles used for breathing, assisted ventilation (artificial respiration) is required during and after surgery until the patient's own breathing returns.
Sugammadex Ranbaxy is used to accelerate the recovery of muscle function after surgery, enabling the patient to breathe independently again sooner. It works by binding to rocuronium bromide or vecuronium bromide in the body.
This medicine may be used in newborns, infants, young children, children, and adolescents (from birth up to 17 years of age) when rocuronium bromide has been administered.

2. Important information before using Sugammadex Ranbaxy

When not to give Sugammadex Ranbaxy

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 immediately.

Warnings and precautions
Before administering Sugammadex Ranbaxy, discuss the following with the anaesthesiologist:
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if the patient has or has previously had kidney disease. This is important because Sugammadex Ranbaxy is eliminated from the body via the kidneys;
if the patient has or has previously had liver disease;
if the patient retains fluids in the body (oedema);
if the patient has conditions known to increase the risk of bleeding (blood clotting disorders), or is taking anticoagulant medicines.

Sugammadex Ranbaxy 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 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 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 Ranbaxy may affect the effectiveness of hormonal contraceptives
Sugammadex Ranbaxy may reduce the effectiveness of hormonal contraceptives, including oral contraceptive pills, vaginal contraceptive systems, implants, or transdermal contraceptive systems releasing progestogen (hormonal intrauterine device), as it reduces the amount of hormone delivered. The amount of progestogen lost due to administration of Sugammadex Ranbaxy is approximately equivalent to missing one oral contraceptive pill.

If taking an oral contraceptive pill on the same day Sugammadex Ranbaxy is administered, follow the instructions for missed pill provided in the hormonal contraceptive’s package leaflet.
If using other hormonal contraceptives (such as a vaginal contraceptive system, 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’s package leaflet.

Effect on blood test results
Generally, Sugammadex Ranbaxy does not affect laboratory test results. However, it may affect blood test results for a hormone called progesterone. Please consult the doctor if progesterone levels need to be measured on the same day Sugammadex Ranbaxy is administered.
Pregnancy and breastfeeding
Inform the anaesthesiologist if the patient is pregnant, suspects pregnancy, or is breastfeeding.
Sugammadex Ranbaxy may still be used in a pregnant patient, but this should be discussed with the doctor. It is not known whether sugammadex passes into human milk. The anaesthesiologist will help decide whether to discontinue breastfeeding or stop treatment with sugammadex, taking into account the benefits of breastfeeding for the child and the benefits of treatment with Sugammadex Ranbaxy for the mother.
Driving and operating machinery
The effect of Sugammadex Ranbaxy on the ability to drive and operate machinery is unknown.
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Sugammadex Ranbaxy contains sodium
This medicine contains 9.7 mg of sodium (the main component of table salt) per millilitre.
Dose less than or equal to 2.4 mL
A dose of 2.4 mL (or less) contains less than 1 mmol of sodium (23 mg) per mL, meaning the medicine is considered "sodium-free".
Dose above 2.4 mL
A dose of 2.4 mL (or more) contains 1 mmol (or more) of sodium (23 mg) per mL. This corresponds to 1.15% (or more) of the maximum recommended daily dietary sodium intake for adults.
Patients on a sodium-controlled diet should inform their anaesthesiologist.

3. How to use Sugammadex Ranbaxy

Sugammadex Ranbaxy 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 Ranbaxy 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 patients of all ages. If rapid reversal of neuromuscular blockade is required, a dose of 16 mg/kg body weight may be used in adults.
How Sugammadex Ranbaxy is administered
Sugammadex Ranbaxy is administered by the anaesthesiologist as a single intravenous injection through an intravenous line.
Administration of a higher than recommended dose of Sugammadex Ranbaxy
Since the anaesthesiologist closely monitors the patient's condition, overdose of Sugammadex Ranbaxy is unlikely. Nevertheless, if such an event occurs, no problems are expected to arise.
If you have any further questions regarding the use of this medicine, consult the anaesthesiologist or another doctor.

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although they do not occur in everyone.
If these adverse reactions occur during anaesthesia, they will be noticed and treated by the anaesthetist.
Common adverse reactions (may occur in up to 1 in 10 people)

Cough
Breathing difficulties, including cough or movement, such as during waking up or taking a breath

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Light anaesthesia – the patient may start 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 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, 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. Allergic reactions have been reported more frequently in healthy, awake volunteers.
Return of muscle tension to normal state after surgery

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

After administration of Sugammadex Ranbaxy, severe cases of slowing of the heart rate, including bradycardia up to and including cardiac arrest, are possible.

Reporting of adverse reactions
If any adverse symptoms occur, including any adverse symptoms not listed in this leaflet, inform your doctor, pharmacist, or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of 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 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 Ranbaxy

The medicine will be stored by healthcare 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.
There are no special storage temperature requirements for this medicine.
Store the vial in the outer packaging to protect from light.
After first opening and dilution, store at a temperature of 2°C to 8°C and use within 24 hours.

6. Contents of the pack and other information

What Sugammadex Ranbaxy contains

The active substance is sugammadex. 1 mL of solution for injection contains 100 mg of sugammadex in the form of sodium sugammadex. Each 2 mL vial contains 200 mg of sugammadex in the form of sodium sugammadex.

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Each 5 mL vial contains 500 mg of sugammadex in the form of sodium sugammadex.

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

What Sugammadex Ranbaxy looks like and contents of the pack
Sugammadex Ranbaxy is a clear, colourless to slightly yellowish-brown solution for injection, practically free from particulate matter.
It is available in two different 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
Ranbaxy (Poland) Sp. z o.o.
Idzikowskiego Street 16
00-710 Warsaw, Poland

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, The Netherlands

Sun Pharmaceutical Industries Europe B.V.
Polarisavenue 87
2132JH Hoofddorp
The Netherlands