Nimbex

NIMBEX 2 mg/ml, solution for injection and infusion

( Cisatracurium)

Read the package leaflet carefully before using the medicine, as it contains

important information for the patient.

• This leaflet should be kept, so that it can be read again if necessary.
• In case of any doubts, the doctor should be consulted.
• If the patient experiences any side effects, including any side effects not listed in the leaflet, the doctor or pharmacist should be informed. See section 4.

Table of contents of the leaflet:

• 1. What is Nimbex and what is it used for
• 2. Important information before using Nimbex
• 3. How to use Nimbex
• 4. Possible side effects
• 5. How to store Nimbex
• 6. Contents of the pack and other information

1. What is Nimbex and what is it used for

Nimbex contains the active substance cisatracurium (as cisatracurium benzenesulfonate) and belongs to a group of muscle relaxants.
Nimbex is used:

• to relax muscles during surgical procedures (including cardiothoracic surgery) in adults and children over 1 month of age,
• to facilitate the introduction of a tube into the trachea (endotracheal intubation), in case the patient needs respiratory support,
• to relax muscles in patients in Intensive Care Units. For more information about the medicine, the doctor should be consulted.

2. Important information before using Nimbex

When not to use Nimbex

• if the patient is allergic (hypersensitive) to cisatracurium, any other muscle relaxant or any of the other ingredients of Nimbex (see section 6),
• if the patient has had an abnormal reaction to anesthetics in the past. If any of the above situations apply to the patient, they should not take Nimbex. In case of doubts, the doctor or nurse should be consulted.

Warnings and precautions

The doctor or nurse should be consulted if:

• the patient has muscle weakness and fatigue or difficulty coordinating movements (myasthenia),
• the patient has a neuromuscular disease, such as muscular dystrophy, paralysis, amyotrophic lateral sclerosis, cerebral palsy,
• the patient has burns that require treatment.

In case of doubts whether any of the above situations apply to the patient, the doctor or nurse should be consulted before using Nimbex.

Nimbex and other medicines

The doctor or nurse should be informed about all medicines the patient is taking or has recently taken, including herbal medicines and medicines that are available without a prescription, as well as medicines that the patient plans to take.
In particular, the doctor should be informed if the patient is taking any of the following medicines:

• anesthetics (used to eliminate sensation and pain during surgical procedures),
• antibiotics (used to treat infections),
• medicines used to treat heart rhythm disorders (antiarrhythmics),
• medicines used to treat high blood pressure,
• diuretics, such as furosemide,
• medicines used to treat joint inflammation, such as chloroquine or D-penicillamine,
• corticosteroids,
• medicines used to treat seizures (epilepsy), such as phenytoin or carbamazepine,
• medicines used to treat mental disorders, such as lithium salts or chlorpromazine (also used as an antiemetic),
• medicines containing magnesium,
• medicines used to treat Alzheimer's disease (acetylcholinesterase inhibitors, e.g. donepezil).

Pregnancy and breastfeeding

The harmful effect of cisatracurium on the breastfed child cannot be excluded, however, it is not expected to have an effect if breastfeeding is resumed after its action has ceased.
Cisatracurium is rapidly eliminated from the body. The woman should not breastfeed for 3 hours after the administration of the medicine has ended.
Before using any medicine, the doctor should be consulted.

Driving and using machines

If the patient is in the hospital for only one day, the doctor will determine the time to wait before leaving the hospital or driving a vehicle. Driving too soon after surgery may be dangerous.

3. How to use Nimbex

The patient will never use this medicine on their own. The medicine will always be administered to the patient by a qualified person.
Nimbex can be administered:

• as a single intravenous injection (intravenous bolus),
• as a continuous intravenous infusion. The medicine is then administered slowly over a long period of time.

The doctor will decide in what form the medicine will be administered and what dose the patient will receive. This will depend on:

• the patient's body weight,
• the required duration and degree of muscle relaxation,
• the patient's expected response to the medicine.

Nimbex should not be used in children under 1 month of age.

Using a higher dose of Nimbex than recommended

Nimbex will be administered under controlled conditions by a doctor. However, if the patient thinks they have been given too much medicine, they should immediately inform the doctor or nurse.

4. Possible side effects

Like all medicines, Nimbex can cause side effects, although not everybody gets them.

Allergic reactions (may occur in less than 1 in 10,000 patients)

In case of an allergic reaction, the doctor or nurse should be informed immediately.
Symptoms may include:

• sudden wheezing, chest pain or tightness
• swelling of the eyelids, face, lips, mouth or tongue
• hives or itching on any surface of the body,
• collapse and shock.

The following symptoms should be reported to the doctor, nurse or pharmacist:

Common side effects (may occur in less than 1 in 10 patients)

• slow heart rate,
• low blood pressure.

Uncommon side effects (may occur in less than 1 in 100 patients)

• skin rash or redness,
• wheezing or coughing.

Rare side effects (may occur in less than 1 in 10,000 patients)

• muscle weakness or pain.

Reporting side effects

If any side effects occur, including any side effects not listed in the leaflet, the doctor or nurse should be informed. 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.: +48 22 49-21-301, fax: +48 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, more information can be collected on the safety of the medicine.

5. How to store Nimbex

The medicine should be stored out of sight and reach of children.
The medicine should not be used after the expiry date stated on the packaging. The expiry date refers to the last day of the month stated.
Store in a refrigerator (2°C – 8°C). Protect from light. Do not freeze.
After dilution, Nimbex should be stored at 2°C – 8°C and used within 24 hours. All unused infusion solution should be discarded within 24 hours of preparation.
Medicines should not be disposed of via wastewater or household waste. The doctor or nurse will dispose of medicines that are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

What Nimbex contains

• The active substance of Nimbex is cisatracurium (as cisatracurium benzenesulfonate).
• The other ingredients are: 32% w/v benzenesulfonic acid solution and water for injections.

What Nimbex looks like and contents of the pack

Nimbex 2 mg/ml solution for injection and infusion is available in packs containing 5 ampoules of 2.5 ml, 5 ml or 10 ml of clear glass.

• Each 2.5 ml ampoule contains 5 mg of cisatracurium.
• Each 5 ml ampoule contains 10 mg of cisatracurium.
• Each 10 ml ampoule contains 20 mg of cisatracurium.

Marketing authorization holder:

Aspen Pharma Trading Limited,
3016 Lake Drive,
Citywest Business Campus,
Dublin 24, Ireland
Tel: 0048 221253376
Manufacturer:
Aspen Pharma Ireland Limited
3016 Lake Drive, Citywest Business Campus
Dublin 24
Ireland
or
GlaxoSmithKline Manufacturing S.p.A.
Strada Provinciale Asolana, 90
43056 San Polo di Torrile
Parma
Italy
or
Importer:
Aspen Bad Oldesloe, GmbH,
Industriestrasse 32-36,
23843 Bad Oldesloe
Germany
Date of last revision of the leaflet:07/2022

Information intended for healthcare professionals only:

Nimbex is intended for single use. Only clear and almost colorless solutions with a tolerance to light yellow or greenish-yellow should be used. The appearance of the solution should be checked before use. If the appearance of the solution has changed or the ampoule is damaged, the product should be discarded.
Nimbex, diluted to concentrations of 0.1 to 2.0 mg/ml, is physically and chemically stable for at least 24 hours, if stored at a temperature of 5°C to 25°C in containers made of polyvinyl chloride (PVC) or polypropylene:

• 0.9% sodium chloride infusion solution,
• 5% glucose infusion solution,
• 0.18% sodium chloride and 4% glucose infusion solution,
• 0.45% sodium chloride and 2.5% glucose infusion solution.

Since Nimbex does not contain preservatives, it should be diluted immediately before use. Otherwise, the storage instructions for the product after opening the ampoule contained in the leaflet in section 5 should be followed.
Under conditions simulating infusion through a Y-shaped connector, Nimbex has been shown to be compatible with the following commonly used perioperative medicines: alfentanil hydrochloride, droperidol, fentanyl citrate, midazolam hydrochloride and sufentanil citrate. If other medicines are administered through the same connector as Nimbex, it is recommended to flush the system with an appropriate infusion solution, e.g. 0.9% sodium chloride infusion solution, after each medicine is administered.
Similarly, as with other intravenously administered medicines, if a small vein is chosen as the injection site, it should be flushed with an appropriate infusion solution, e.g. 0.9% sodium chloride infusion solution, after Nimbex is administered.