Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - sugammadex

Document Subject

Generated Narrative: MedicinalProductDefinition mp16018c8f310d03d6a566ded2f2a2880a

identifier: http://ema.europa.eu/identifier/EU/1/23/1739/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Sugammadex Piramal 100 mg/mL solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

part

part: nan

type: Strength part

part

part: nan

type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-16018c8f310d03d6a566ded2f2a2880a

identifier: http://ema.europa.eu/identifier/EU/1/23/1739/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - sugammadex

Attesters

What is in this leaflet

1. What Sugammadex Piramal is and what it is used for
2. What you need to know before Sugammadex Piramal is given
3. How Sugammadex Piramal is given
4. Possible side effects
5. How to store Sugammadex Piramal
6. Contents of the pack and other information

What Sugammadex Piramal is Sugammadex Piramal contains the active substance sugammadex. Sugammadex Piramal is considered to be a selective relaxant binding agent since it only works with specific muscle relaxants, rocuronium bromide or vecuronium bromide.

What Sugammadex Piramal is used for

When you have some types of operations, your muscles must be completely relaxed. This makes it easier for the surgeon to do the operation. For this, the general anaesthetic you are given includes medicines to make your muscles relax. These are called muscle relaxants, and examples include rocuronium bromide and vecuronium bromide. Because these medicines also make your breathing muscles relax, you need help to breathe (artificial ventilation) during and after your operation until you can breathe on your own again. Sugammadex Piramal is used to speed up the recovery of your muscles after an operation to allow you to breathe on your own again earlier. It does this by combining with the rocuronium bromide or vecuronium bromide in your body. It can be used in adults whenever rocuronium bromide or vecuronium bromide is used and in children and adolescents (aged 2 to 17 years) when rocuronium bromide is used for a moderate level of relaxation.

You should not be given Sugammadex Piramal

• if you are allergic to sugammadex or any of the other ingredients of this medicine (listed in section 6). Tell your anaesthetist if this applies to you.

Warnings and precautions

Talk to your anaesthetist before Sugammadex Piramal is given

• if you have kidney disease or had in the past. This is important as this medicine is removed from
• your body by the kidneys.
• if you have liver disease or have had it in the past.
• if you have fluid retention (oedema).
• if you have diseases which are known to give an increased risk of bleeding (disturbances of blood clotting) or anticoagulation medicine.

Children and adolescents

This medicine is not recommended for infants less than 2 years of age.

Other medicines and Sugammadex Piramal

Tell your anaesthetist if you are taking, have recently taken or might take any other medicines. Sugammadex Piramal may affect other medicines or be affected by them.

Some medicines reduce the effect of Sugammadex Piramal

It is especially important that you tell your anaesthetist if you have recently taken:

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

Sugammadex Piramal can affect hormonal contraceptives

Sugammadex Piramal can make hormonal contraceptives - including the Pill , vaginal ring, implants or a hormonal Intra Uterine System (IUS) - less effective because it reduces how much you get of the progestogen hormone. The amount of progestogen lost by using Sugammadex Piramal is about the same as missing one oral contraceptive Pill. If you are taking the Pill on the same day as Sugammadex Piramal is given to you, follow the instructions for a missed dose in the Pill s package leaflet. If you are using other hormonal contraceptives (for example a vaginal ring, implant or IUS) you should use an additional non-hormonal contraceptive method (such as a condom) for the next 7 days and follow the advice in the package leaflet.

Effects on blood tests

In general, Sugammadex Piramal does not have an effect on laboratory tests. However, it may affect the results of a blood test for a hormone called progesterone. Talk to your doctor if your progesterone levels need to be tested on the same day you receive Sugammadex Piramal.

Pregnancy and breast-feeding

Tell your anaesthetist if you are pregnant or might be pregnant or if you are breast-feeding. You may still be given Sugammadex Piramal, but you need to discuss it first. It is not known whether sugammadex can pass into breast milk. Your anaesthetist will help you decide whether to stop breast-feeding, or whether to abstain from sugammadex therapy, considering the benefit of breast-feeding to the baby and the benefit of Sugammadex Piramal to the mother.

Driving and using machines

Sugammadex Piramal has no known influence on your ability to drive and use machines.

Sugammadex Piramal contains sodium

This medicine contains up to 9.7 mg sodium (main component of cooking / table salt) in each mL. This is equivalent to 0.5 % of the recommended maximum daily dietary intake of sodium for an adult.

Sugammadex Piramal will be given to you by your anaesthetist, or under the care of your anaesthetist.

The dose

Your anaesthetist will work out the dose of Sugammadex Piramal you need based on:

• your weight
• how much the muscle relaxant medicine is still affecting you. The usual dose is 2-4 mg per kg body weight for adults and for children and adolescents between 2- 17 years old. A dose of 16 mg/kg can be used in adults if urgent recovery from muscle relaxation is needed.

How Sugammadex Piramal is given

Sugammadex Piramal will be given to you by your anaesthetist. It is given as a single injection through an intravenous line.

If more Sugammadex Piramal is given to you than recommended

As your anaesthetist will be monitoring your condition carefully, it is unlikely that you will be given too much Sugammadex Piramal. But even if this happens, it is unlikely to cause any problems.

If you have any further questions on the use of this medicine, ask your anaesthetist or other doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them. If these side effects occur while you are under anaesthesia, they will be seen and treated by your anaesthetist.

Common side effects (may affect up to 1 in 10 people)

• Cough
• Airway difficulties that may include coughing or moving as if you are waking or taking a breath
• Light anaesthesia - you may start to come out of deep sleep, so need more anaesthesia. This might cause you to move or cough at the end of the operation
• Complications during your procedure such as changes in heart rate, coughing or moving
• Decreased blood pressure due to the surgical procedure

Uncommon side effects (may affect up to 1 in 100 people)

• Shortness of breath due to muscle cramps of the airways (bronchospasm) occurred in patients with a history of lung problems
• Allergic (drug hypersensitivity) reactions - such as a rash, red skin, swelling of your tongue and/or throat, shortness of breath, changes in blood pressure or heart rate, sometimes resulting in a serious decrease of blood pressure. Severe allergic or allergic-like reactions can be life threatening. Allergic reactions were reported more commonly in healthy, conscious volunteers
• Return of muscle relaxation after the operation

Not known (frequency cannot be estimated from the available data)

• Severe slowing of the heart and slowing of the heart up to cardiac arrest may occur when Sugammadex Piramal is administered Reporting of side effects

If you get any side effects, talk to your anaesthetist or other doctor. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system
listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

Storage will be handled by healthcare professionals. Keep this medicine out of the sight and reach of children. Do not use this medicine after the expiry date which is stated on the carton and on the label after EXP . The expiry date refers to the last day of that month.

Keep the vial in the outer carton in order to protect from light. After first opening and dilution, store at 2 to 8 C and use within 48 hours.

What Sugammadex Piramal contains

• The active substance is sugammadex. 1 mL solution for injection contains sugammadex sodium equivalent to 100 mg sugammadex. Each vial of 2 mL contains sugammadex sodium equivalent to 200 mg sugammadex. Each vial of 5 mL contains sugammadex sodium equivalent to 500 mg sugammadex.

• The other ingredients are water for injections, hydrochloric acid and/or sodium hydroxide (for pH adjustment). (see section 2 Sugammadex Piramal contains sodium).

What Sugammadex Piramal looks like and contents of the pack

Sugammadex Piramal is a clear and colourless to slightly yellow brown solution for injection. It comes in two different pack sizes, containing either 10 vials with 2 mL or 10 vials with 5 mL solution for injection. Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Piramal Critical Care B.V Rouboslaan 32, 2252 TR Voorschoten The Netherlands

This leaflet was last revised in June 2Detailed information on this medicine is available on the European Medicines Agency web site: